Infusion Pump System and Methods

ABSTRACT

Some embodiments an infusion pump system can be configured to activate an alarm in response to a calculated prediction of the user&#39;s future blood glucose levels. Optionally, the predictive calculation of the user&#39;s future blood glucose levels can be based at least in part upon a recent blood glucose level, a trend of blood glucose levels over time, and an insulin load of the user.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of and claims priority toU.S. application Ser. No. 13/652,905, filed on Oct. 16, 2012.

TECHNICAL FIELD

This disclosure relates to portable infusion pump systems to deliverfluids, such as0 insulin infusion pump systems or the like.

BACKGROUND

Pump devices are commonly used to deliver one or more fluids to atargeted individual. For example, a medical infusion pump device may beused to deliver a medicine to a patient as part of a medical treatment.The medicine that is delivered by the infusion pump device can depend onthe condition of the patient and the desired treatment plan. Forexample, infusion pump devices have been used to deliver insulin to thevasculature of diabetes patients so as to regulate blood glucose levels.

Some embodiments of a medical infusion pump system can include acontinuous glucose monitoring device for providing feedback data (e.g.,blood glucose levels) to the infusion pump. The infusion pump, in turn,can process the data using its controller, which may take or suggestactions in response to the data. For example, the infusion pump'scontroller can provide an alarm if the blood glucose level is above orbelow a generally safe range.

In some embodiments, an insulin pump's controller may also provide analarm if the controller predicts the patient's future blood glucoselevel will go above or below a threshold level. But, the ability of apump's control algorithms to make an accurate prediction of thepatient's future blood glucose level can be adversely affected bycertain factors. For example, in some circumstances, the dosage ofmedicine delivered by the infusion pump acts within the patient's bodyover a long period of time. Such conditions, for example, may cause apatient to have an amount of non-activated insulin in his or her systemeven hours after the insulin dosage was dispensed from the infusion pumpdevice. If this non-activated insulin is not taken into account by thepump's controller when predicting the patient's future blood glucoselevels, the accuracy of the prediction will be adversely affected.Similarly, it may take hours for food that was consumed by a patient toimpart its full effect on the patient's blood glucose levels. In somecircumstances, this factor can affect the accuracy of the blood glucoseprediction.

SUMMARY

Some embodiments of an infusion pump system can provide an alarm (e.g.,an alert, a safety alarm, or the like) and initiate or suggest othercountermeasures in response to a predicted condition that exceeds analarm limit parameter. In some circumstances, the infusion pump systemcan be configured to predict the user's future blood glucose level basedat least in part upon the user's current blood glucose level, the trendof the user's blood glucose level, the user's insulin load (e.g., anestimated value of previously dispensed insulin that has not yet actedin the user's body), and optionally, the user's food-on-board (e.g., anestimate of the carbohydrate value (or other food value) consume by theuser that has not yet acted on the user, for example, metabolized forconversion into glucose).

Accordingly, if the predicted blood glucose level is outside the definedlimit parameters, some embodiments of the infusion pump system mayprovide an alert that, for example, prompts the user to approve one ormore countermeasures for purposes of preventing the user's bloodglucoses level from actually reaching the threshold level in the future.Such a predictive feature can be valuable to a user when the infusionpump is operated in conjunction with a blood glucose monitoring device.Methods to provide the user with a greater scope of information andgreater control regarding their blood glucose level are provided herein.Moreover, the infusion pump system can be configured to provide anindication to a user that a blood glucose level in the future (e.g., apredicted blood glucose level) may reach an upper or lower thresholdlevel, and thus the infusion pump system can suggest to the user to“consume carbohydrates” or “reduce insulin dose” (e.g., if the predictedblood glucose level is below a lower threshold limit) or suggest to theuser to “increase insulin dosage” or “avoid consuming carbohydrates”(e.g., if the predicted glucose level is above an upper thresholdlimit). Such a result can be used to reduce the likelihood of the user'sblood glucose level reaching an alarm limit, thereby more consistentlymaintaining the user's blood glucose level within a desired range overan extended period of time.

Particular embodiments described herein include a medical infusion pumpsystem. The system may include a portable pump housing that receivesinsulin for dispensation to a user, and the pump housing may at leastpartially containing a pump drive system to dispense the insulin througha flow path to the user. The system may also include a controller thatcommunicates with the pump drive system to dispense the insulin from theportable pump housing. Optionally, the controller can be embodied as aremovable controller device that is configured to releasably attach tothe pump housing. The system may further include a monitoring devicethat communicates glucose information to the controller, and the glucoseinformation may be indicative of a blood glucose level of the user. Thecontroller can be configured to predict a future blood glucose level ofthe user based at least in part upon a recent blood glucose level, atrend of blood glucose levels over time, and an insulin load of theuser. The controller may be configured to output an alarm in response tothe predicted future blood glucose level being less than a lowerthreshold value or greater than a higher threshold value.

Some embodiments described herein include a controller for an insulininfusion pump system. The controller may include a processor, and one ormore computer-readable memory devices to store the glucose informationreceived from the monitoring device and time values associated with theglucose information. The one or more computer-readable memory devicesmay also store computer-readable instructions for a blood glucoseprediction process that, when executed by the processor, cause thecontroller to perform a number of operations. The computer-readableinstructions for the blood glucose prediction process may cause thecontroller to calculate a predicted future blood glucose level of theuser based at least in part upon a recent blood glucose level of a user,a trend of blood glucose levels over time, and an insulin load of theuser. The computer-readable instructions for the blood glucoseprediction process may cause the controller to output an alarm inresponse to the predicted future blood glucose level being less than alower threshold value. The computer-readable instructions for the bloodglucose prediction process may cause the controller to operate in a lowglucose recovery mode in response to user input that accepts activationof the low glucose recovery mode. Optionally, the controller can beembodied as a removable controller device that is configured toreleasably attach to a pump housing for dispensing insulin.

Other embodiments described herein include a method of operating aninsulin infusion pump system. The method may include receiving, at acontroller of an insulin infusion pump system, glucose informationindicative of a glucose level of a user. The method may also includedetermining an insulin load value indicative of an estimated value ofpreviously dispensed insulin that has not yet acted in the user. Themethod may further include calculating, at the controller of the insulininfusion pump system, a predicted future blood glucose level of the userbased at least in part upon a recent glucose level of the user, a trendof blood glucose levels over time, and the insulin load of the user. Themethod may also include, in response to the predicted future bloodglucose level being less than a lower threshold value or greater than ahigher threshold value, outputting an alarm from the insulin infusionpump system. Optionally, the controller can be embodied as a removablecontroller device that is configured to releasably attach to a pumphousing of the insulin infusion pump system.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a perspective view of an infusion pump system, in accordancewith some embodiments.

FIG. 2 is a perspective exploded view of an infusion pump assembly ofthe system of FIG. 1.

FIG. 3 is a perspective view of the infusion pump system of FIG. 1 inwhich the pump assembly is worn on clothing of a user, in accordancewith particular embodiments.

FIG. 4 is a perspective view of an infusion pump system of FIG. 1 inwhich the pump assembly is worn on skin of a user, in accordance withother embodiments.

FIGS. 5-6 are perspective views of a pump device being detached from acontroller device of the system of FIG. 1, in accordance with someembodiments.

FIGS. 7-8 are perspective views of the pump device of FIGS. 5-6 beingdiscarded and the controller device of FIGS. 5-6 being reused with a newpump device.

FIG. 9 is an exploded perspective view of a controller device for aninfusion pump system, in accordance with some embodiments.

FIG. 10 is a perspective view of a portion of a pump device for aninfusion pump system, in accordance with particular embodiments.

FIG. 11 is a flow diagram depicting an exemplary process used todetermine a user's predicted blood glucose level, in accordance withsome embodiments.

FIG. 12 is a diagram depicting an example of an insulin decay curve,which may be employed in the determination of the user's total insulinload (TIL) or insulin-on-board (IOB) in accordance with someembodiments.

FIG. 13 is a diagram depicting an example of a user's blood glucoselevel trend, in accordance with some embodiments.

FIG. 14 is a flow diagram depicting an example of a process foroperating an insulin infusion pump when a low blood glucose event hasbeen predicted, in accordance with some embodiments.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIG. 1, an infusion pump system 10 can include a pumpassembly 60 used to supply insulin or other medication to a user via,for example, an infusion set 70. In some embodiments, a glucosemonitoring device 50 can be in communication with the infusion pumpassembly 60 for the purpose of supplying data indicative of a user'sblood glucose level to a controller device 200 included in the pumpassembly 60. The infusion pump system 10 can utilize the data indicativeof a user's blood glucose level to, for example, provide an alarm (e.g.,an audible or textual safety alarm, an audible or textual alertnotification, or another type of alarm) when the user's blood glucoselevel falls below a low glucose alarm limit or rises above a highglucose alarm limit. In some embodiments, as described further below inconnection with FIGS. 11-14, the user's blood glucose data can beemployed by the controller device 200 to predict the user's future bloodglucose level. If the predicted blood glucose level is below a loweralarm limit, the controller device 200 can provide an alarm (e.g.,audible, visual such as the display 222 of FIG. 1, or both) and promptthe user to approve particular countermeasures.

In some embodiments, the infusion pump system 10 can be configured tosupply scheduled basal dosages of insulin (or other medication) alongwith user-selected bolus dosages. The basal rate can be selected tomaintain a user's blood glucose level in a target range during normalactivity when the user is not eating or otherwise consuming food items.The selected bolus deliveries may provide substantially larger amountsof insulin to limit the blood glucose level during certaincircumstances, such as the consumption of carbohydrates and other fooditems (e.g., a “meal bolus”) or to lower an elevated glucose level(e.g., a “correction bolus”). Due in part to pharmacokinetic effects(e.g., the time it takes for insulin to enter the blood stream from thesubcutaneous point of delivery) and pharmacodynamic effects (e.g., thetime it takes for a concentration of insulin in the blood to have thephysiological effect of lower blood glucose level), basal and bolusinsulin dispensed into the user's system may not act instantaneously,but instead may act over a period of time to control the user's bloodglucose level. As such, the user's body may include some amount ofinsulin that has not yet acted even while the infusion pump assembly 60is activated to deliver additional dosages (basal, bolus, or acombination thereof). In these circumstances, the infusion pump assembly60 can be used to determine a user's total insulin load (TIL), which canprovide an estimate of the total amount of insulin which has beendelivered but has not yet acted in the user's body. As described herein,the phrase “total insulin load” can include an estimate of previouslydispensed insulin, such as the sum of recent bolus and basal activity,and may preferably include an estimated value of previously dispensedinsulin that has not yet acted in the user's body. Alternatively, theinfusion pump assembly 60 can be used to determine a user'sinsulin-on-board (IOB), which is an estimate based upon only bolusdosages that have been delivered but have not yet acted in the user'sbody.

In some embodiments, the controller device 200 can determine a user'sTIL information (e.g., a user's TIL value, TIL % value, or the like) ina manner that accounts for both the bolus deliveries and the basaldeliveries (not merely bolus deliveries alone, as is typical withinsulin-on-board estimations). As described in more detail below, thisprocess for determining a user's TIL value can accurately reflect basalrate changes and bolus infusions. For example, in some embodiments, auser can have different basal rates depending on the time of day (e.g.,a higher basal rate during some parts of the day, a lower basal rateduring the night, etc.) In further embodiments, the TIL information canbe determined by the controller device 200 in a manner that alsoaccounts for the user's previously consumed food (along with theprevious basal and bolus deliveries). As described in more detail below,such a process for determining the TIL information can quantify both thepreviously dispensed insulin that has not yet acted on the user and thepreviously consumed food that has not yet been metabolized.

In some embodiments, data related to a user's insulin load, such as TILvalues (or IOB estimates) and the times at which they were calculated,can be stored in one or more memory devices (described below) of thecontroller device 200. As described in more detail below in connectionwith FIGS. 11-14, this data can be advantageously used, for example, bythe controller device 200 in a process to more accurately predict futureblood glucose levels. For instance, generally, if a user's insulin load(TIL or IOB) is higher than normal, the chances of the user's bloodglucose level falling is more likely. In these circumstances, thecontroller device 200 can employ not only the most recently measuredblood glucose level and the more recent trend data of the user's bloodglucose levels, but the controller device 200 can also account for theuser's insulin load (TIL or IOB) so as to more accurately assess whetherthe user's future blood glucose level will fall below a lower alarmlimit. In response to such a determination by a predictive blood glucosealgorithm executed by the controller device 200, the controller device200 may provide enhanced user safety by providing an alarm which canalert the user to a potentially dangerous upcoming decrease in bloodglucose level sooner than if the low blood glucose level was notpredicted (or was predicted based merely upon the trend data of previousglucose level measurements).

Optionally, in some embodiments, the user's blood glucose information(including a current blood glucose level and a recent trend of bloodglucose levels) and the TIL or IOB values can be augmented with afood-on-board estimation. Again, as described below in connection withFIGS. 11-14, such factors can be input to the predictive algorithmexecuted by the controller device 200 and used to calculate an estimatedfuture blood glucose level. The controller device 200 can provide alarms(such as safety alarms, alert notifications, or the like) indicatingthat a predicted “high” or “low” blood glucose level is likely to occur.Such alarms can benefit the user in that this information can be used bythe controller device 200 to prompt corrective action (e.g., promptingthe user to eat, prompting the user for input in order to suggest abolus dosage, or the like) before the user's blood glucose level hasrisen or fallen out of a normal range.

Still referring to FIG. 1, the glucose monitoring device 50 can includea housing 52, a wireless communication device 54, and a sensor shaft 56.The wireless communication device 54 can be contained within the housing52 and the sensor shaft 56 can extend outward from the housing 52. Inuse, the sensor shaft 56 can penetrate the skin 20 of a user to makemeasurements indicative of characteristics of the user's blood (e.g.,the user's blood glucose level or the like). In response to themeasurements made by the sensor shaft 56, the glucose monitoring device50 can employ the wireless communication device 54 to transmit data tothe controller device 200 of the pump assembly 60.

In some embodiments, the monitoring device 50 may include a circuit thatpermits sensor signals (e.g., data from the sensor shaft 56) to becommunicated to the communication device 54. The communication device 54can transfer the collected data to the infusion pump assembly 60 (e.g.,by wireless communication to a communication device 247 arranged in thepump assembly 60). In some embodiments, the monitoring device 50 canemploy other methods of obtaining information indicative of a user'sblood characteristics and transferring that information to the infusionpump assembly 60. For example, an alternative monitoring device mayemploy a micropore system in which a laser porator creates tiny holes inthe uppermost layer of a user's skin, through which interstitial glucoseis measured using a patch. Alternatively, the monitoring device can useiontophoretic methods to non-invasively extract interstitial glucose formeasurement. In other examples, the monitoring device can includenon-invasive detection systems that employ near IR, ultrasound orspectroscopy, and particular embodiments of glucose-sensing contactlenses. Invasive methods involving optical means of measuring glucosecould also be added. In yet another example, the monitoring device caninclude an optical detection instrument that is inserted through theskin for measuring the user's glucose level.

Furthermore, it should be understood that in some embodiments, themonitoring device 50 can be in communication with the pump assembly 60via a wired connection. In other embodiments of the pump system 10, teststrips (e.g., blood test strips) containing a sample of the user's bloodcan be inserted into a strip reader portion of the pump assembly 60 tobe tested for characteristics of the user's blood. Alternatively, thetest strips (e.g., glucose test strips) containing a sample of theuser's blood can be inserted into a glucose meter device (not shown inFIG. 1), which then analyzes the characteristics of the user's blood andcommunicates the information (via a wired or wireless connection) to thepump assembly 60. In still other embodiments, characteristics of theuser's blood glucose information can be entered directly into the pumpsystem 10 via a user interface on the controller device 200.

Referring now to FIGS. 1-2, the infusion pump assembly 60 can include apump device 100 and the controller device 200 that communicates with thepump device 100. The pump device 100 includes a housing structure 110that defines a cavity 116 in which a fluid cartridge 120 can bereceived. The pump device 100 also includes a cap device 130 to retainthe fluid cartridge 120 in the cavity 116 of the housing structure 110.The pump device 100 includes a drive system (described in more detailbelow in connection with FIG. 10) that advances a plunger 125 in thefluid cartridge 120 so as to dispense fluid therefrom. In someembodiments, the dispensed fluid exits the fluid cartridge 120, passesthrough a flexible tube 72 of the infusion set 70 to a cannula housing74. The dispensed fluid can enter through the skin via a cannula 76attached to the underside of the cannula housing 74.

In some embodiments, the controller device 200 communicates with thepump device 100 to control the operation of the pump drive system. Whenthe controller device 200, the pump device 100 (including the cap device130 in this embodiment), and the fluid cartridge 120 are assembledtogether, the user may conveniently wear the infusion pump assembly 60on the user's skin under clothing or in the user's pocket whilereceiving the fluid dispensed from the pump device 100 (refer, forexample, to FIGS. 3-4). Thus, in some embodiments, the pump assembly canoperate as a portable unit that provides reliable delivery of insulin oranother medication in a discrete manner.

As described in more detail below, the controller device 200 may beconfigured as a reusable component that provides electronics and a userinterface to control the operation of the pump device 100. In suchcircumstances, the pump device 100 can be a disposable component that isdisposed of after a single use. For example, the pump device 100 can bea “one time use” component that is thrown away after the fluid cartridge120 therein is exhausted. Thereafter, the user can removably attach anew pump device 100 to the reusable controller device 200 for thedispensation of fluid from a new fluid cartridge 120. Accordingly, theuser is permitted to reuse the controller device 200 (which may includecomplex or valuable electronics) while disposing of the relativelylow-cost pump device 100 after each use. Such a pump assembly 60 canprovide enhanced user safety as a new pump device 100 (and drive systemtherein) is employed with each new fluid cartridge 120.

Briefly, in use, the pump device 100 can be configured to removablyattach to the controller device 200 in a manner that provides a securefitting, an overall compact size, and a reliable electrical connection.The compact size permits the infusion pump assembly 60 to be discreteand portable. As described in more detail below, the controller device200 of the infusion pump system can be used to provide glucose alarmsindicative of high and low blood glucose levels (when compared topredetermined high and low blood glucose alarm levels, respectively) andto predict high and low blood glucose levels based on insulin loadinformation (e.g., TIL, IOB, TIL % value, and the like), blood glucosedata, and, optionally, food-on-board information.

It should be understood that, in alternative embodiments, the pumpdevice 100 and the controller device 200 can be configured as a singleunit in which the control components and the pump drive system arearranged in a single housing. In these alternative embodiments, the pumpassembly (including the controller device and the pump device) may havea different size and shape and may operate as a reusable unit that cancommunicate with a number of monitoring devices 50 over a period oftime.

Referring again to FIGS. 1-2, in some embodiments, the pump system 10 isa medical infusion pump system that is configured to controllablydispense a medicine from the cartridge 120. As such, the fluid cartridge120 may contain a medicine 126 to be infused into the tissue orvasculature of a targeted individual, such as a human or animal patient.For example, the pump device 100 can be adapted to receive a medicinecartridge 120 in the form of a carpule that is preloaded with insulin oranother medicine for use in the treatment of Diabetes (e.g., Byetta®,Symlin®, or others). Such a cartridge 120 may be supplied, for example,by Eli Lilly and Co. of Indianapolis, Ind. Other examples of medicinescontained in the fluid cartridge 120 include: medicines to treat primaryimmune deficiency (e.g., Vivaglobin® by CSL Behring of King of Prussia,Pa.), pain relief drugs, hormone therapy, blood pressure treatments,anti-emetics, osteoporosis treatments, or other injectable medicines.The medicine dispensed from the cartridge 120 into the user's system mayact over a period of time in the user's body. As such, the user's bodymay include some amount of medicine that has not yet acted even whilethe infusion pump assembly 60 is activated to deliver additional dosagesof the medicine (basal, bolus, or both). The infusion pump assembly 60can be used to determine a user's total medicine load that provides anaccurate indication of the medicine which has not yet acted in theuser's body. The total medicine load can be determined by the controllerdevice 200 in a manner that accounts for both the bolus deliveries andthe basal deliveries of the medicine (similar to the process fordetermining the total insulin load as described below). It should beunderstood from the description herein that the fluid cartridge 120 mayhave a configuration other than that depicted in FIG. 2. For example,the fluid cartridge may have a different outer shape or a differentreservoir volume. In another example, the fluid cartridge may comprise areservoir that is integral with the pump housing structure 110 (e.g.,the fluid cartridge can be defined by one or more walls of the pumphousing structure 110 that surround a plunger to define a reservoir inwhich the medicine is injected or otherwise received).

In some embodiments, the pump device 100 may include one or morestructures that interfere with the removal of the medicine cartridge 120after the medicine cartridge 120 is inserted into the cavity 116. Forexample, as shown in FIG. 2, the pump housing structure 110 may includeone or more retainer wings 119 that at least partially extend into thecavity 116 to engage a portion of the medicine cartridge 120 when themedicine cartridge 120 is installed therein. In this embodiment, thepump housing structure 110 includes a pair of opposing retainer wings119 (only one is shown in the view in FIG. 2) that flex toward the innersurface of the cavity 116 during insertion of the medicine cartridge120. After the medicine cartridge is inserted to a particular depth, theretainer wings 119 are biased to flex outward (toward the center of thecavity 116) so that the retainer wings 119 engage a neck portion 129 ofthe medicine cartridge 120. This engagement with the retainer wings 119and the neck portion 129 hinder any attempts to remove the medicinecartridge 120 away from the pump device 100. Alternative embodiments caninclude other features and/or configurations to hinder the removal ofthe medicine cartridge 120.

Embodiments of the pump device 100 that hinder the removal of themedicine cartridge 120 may facilitate the “one-time-use” feature of thepump device 100. Because the retainer wings 119 can interfere withattempts to remove the medicine cartridge 120 from the pump device 100,the pump device 100 will be discarded along with the medicine cartridge120 after the medicine cartridge 120 is emptied, expired, or otherwiseexhausted. The retainer wings 119 may serve to hinder attempts to removethe exhausted medicine cartridge 120 and to insert a new medicinecartridge 120 into the previously used pump device 100. Accordingly, thepump device 100 may operate in a tamper-resistant and safe mannerbecause the pump device 100 can be designed with predetermined lifeexpectancy (e.g., the “one-time-use” feature in which the pump device isdiscarded after the medicine cartridge 120 is emptied, expired, orotherwise exhausted).

Still referring to FIGS. 1-2, the cap device 130 can be joined with thepump device 100 after the medicine cartridge is inserted in the cavity116. It should be understood that the cap device 130 may supplement orreplace the previously described retainer wings 119 by locking intoposition after joining with the pump housing 110, thereby hinderingremoval of the fluid cartridge 120 in the pump housing 110. As shown inFIGS. 1-2, the cap device 130 may include an output port 139 thatconnects with the tubing 72 for dispensation of the medicine to theuser. In some embodiments, the output port 139 may have an angledorientation such that a portion of the tubing extends transversely tothe central axis of the cartridge 120 and cap device 130. The outputport 139 can be configured to mate with tubing 72 of the infusion set 70(FIG. 1).

In some embodiments, the controller device 200 may be removably attachedto the pump device 100 so that the two components are mechanicallymounted to one another in a fixed relationship. Such a mechanicalmounting can form an electrical connection between the removablecontroller device 200 and the pump device 100. For example, thecontroller device 200 may be in electrical communication with a portionof a drive system (described in connection with FIG. 10) of the pumpdevice 100. As described in more detail below, the pump device 100includes a drive system that causes controlled dispensation of themedicine or other fluid from the cartridge 120. In some embodiments, thedrive system incrementally advances a piston rod longitudinally into thecartridge 120 so that the fluid is forced out of an output end 122. Theseptum 121 at the output end 122 of the fluid cartridge 120 can bepierced to permit fluid outflow when the cap device 130 is connected tothe pump housing structure 110. Thus, when the pump device 100 and thecontroller device 200 are attached and thereby electrically connected,the controller device 200 communicates electronic control signals via ahardwire-connection (e.g., electrical contacts or the like) to the drivesystem or other components of the pump device 100. In response to theelectrical control signals from the controller device 200, the drivesystem of the pump device 100 causes medicine to incrementally dispensefrom the medicine cartridge 120.

The controller device 200 may be configured to removably attach to thepump device 100, for example, in a side-by-side arrangement. The compactsize permits the infusion pump assembly 60 to be discrete and portablewhen the pump device 100 is attached with the controller device 200 (asshown in FIG. 1). In this embodiment, the controller device 200 includesa controller housing structure 210 having a number of features that areconfigured to mate with complementary features of the pump housingstructure 110 so as to form a releasable mechanical connection(described below in more detail in connection with FIGS. 5-7). Suchmating features of the pump housing structure 110 and the controllerhousing structure 210 can provide a secure connection when thecontroller device 200 is attached to the pump device 100

As shown in FIG. 2, the pump device 100 may include an electricalconnector 118 (e.g., having conductive pads, pins, or the like) that areexposed to the controller device 200 and that mate with a complementaryelectrical connector (refer to connector 218 in FIG. 6) on the adjacentface of the controller device 200. The electrical connectors 118 and 218provide the electrical communication between the control circuitry(refer, for example, to FIG. 9) housed in the controller device 200 andat least a portion of the drive system or other components of the pumpdevice 100. In some exemplary embodiments, the electrical connectors 118and 218 permit the transmission of electrical control signals to thepump device 100 and the reception of feedback signals (e.g., sensorsignals) from particular components within the pump device 100.Furthermore, as described in more detail below, the infusion pumpassembly 60 may include a gasket 140 that provides a seal which isresistant to migration of external contaminants when the pump device 100is attached to the controller device 200. Thus, in some embodiments, thepump device 100 and the controller device 200 can be assembled into awater resistant configuration that protects the electricalinterconnection from water migration (e.g., if the user encounters waterwhile carrying the pump assembly 60).

Referring again to FIGS. 1-2, the controller device 200 includes theuser interface 220 that permits a user to monitor the operation of thepump device 100. In some embodiments, the user interface 220 includes adisplay 222 and one or more user-selectable buttons (e.g., four buttons224 a, 224 b, 224 c, and 224 d in this embodiment). The display 222 mayinclude an active area in which numerals, text, symbols, images, or acombination thereof can be displayed. For example, the display 222 maybe used to communicate a number of status indicators, alarms, settings,and/or menu options for the infusion pump system 10. In someembodiments, the display 222 can indicate an alarm indicative of a highor low blood glucose level, high or low insulin load, the user's currentIOB or TIL information, the user's blood glucose level, an indicationthat the user's blood glucose level is rising or falling, an indicationthat a blood glucose alarm level was modified, and the like. In theexample depicted in FIG. 1, the display 222 indicates that an alert inwhich the controller device 200 has predicted that the user is likely toexperience a low blood glucose level in the near future. In thisembodiment, the display 222 also prompts the user to indicate whether heor she wants the pump device 100 to enter into a low glucose recoverymode so as to reduce the likelihood that the low blood glucose level (aspredicted above) will actually occur, thereby helping the user tomaintain blood glucose levels within the normal range.

In some embodiments, the user may press one or more of the buttons 224a, 224 b, 224 c, and 224 d to shuffle through a number of menus orprogram screens that show particular status indicators, settings, and/ordata (e.g., review data that shows the medicine dispensing rate, thetotal amount of medicine dispensed in a given time period, the amount ofmedicine scheduled to be dispensed at a particular time or date, theapproximate amount of medicine remaining in the cartridge 120, or thelike). In some embodiments, the user can adjust the settings orotherwise program the controller device 200 by pressing one or morebuttons 224 a, 224 b, 224 c, and 224 d of the user interface 220. Forexample, in embodiments of the infusion pump system 10 configured todispense insulin, the user may press one or more of the buttons 224 a,224 b, 224 c, and 224 d to change the dispensation rate of insulin or torequest that a bolus of insulin be dispensed immediately or at ascheduled, later time.

The display 222 of the user interface 220 may be configured to displayalarm information when no buttons 224 a, 224 b, 224 c, and 224 d havebeen pressed. For example, as shown in FIG. 1, the active area of thedisplay 222 can display an alert indicating that the controller device200 has predicted that the user will experience a low glucose levelbased at least in part upon the user's most recently measured bloodglucose level, the trend of the user's blood glucose level over a recentperiod of time, the user's insulin load (e.g., TIL or IOB), andoptionally, the user's food-on-board. The display 222 can also displaythe user's most recently measured blood glucose level (103 mg/dl in thisexample) and an indication of whether the user's blood glucose level isrising or falling (the downward facing arrow indicates a falling glucoselevel in this example). This information can be displayed until one ofthe buttons 224 a, 224 b, 224 c, and 224 d has been actuated. This, orother, information can also be displayed for a period of time after nobutton 224 a, 224 b, 224 c, and 224 d has been actuated (e.g., fiveseconds, 10 seconds, 30 seconds, 1 minute, 5 minutes, or the like).Thereafter, the display 222 may enter sleep mode in which the activearea is blank, thereby conserving battery power. In addition or in thealternative, the active area can display particular device settings,such as the current dispensation rate or the total medicine dispensed,for a period of time after no button 224 a, 224 b, 224 c, or 224 d hasbeen actuated (e.g., five seconds, 10 seconds, 30 seconds, 1 minute, 5minutes, or the like). Again, thereafter the display 222 may enter sleepmode to conserve battery power. In certain embodiments, the display 222can dim after a first period of time in which no button 224 a, 224 b,224 c, or 224 d has been actuated (e.g., after 15 seconds or the like),and then the display 22 can enter sleep mode and become blank after asecond period of time in which no button 224 a, 224 b, 224 c, or 224 dhas been actuated (e.g., after 30 seconds or the like). Thus, thedimming of the display device 222 can alert a user viewing the displaydevice 222 when the active area 223 of the display device will soonbecome blank.

Accordingly, when the controller device 200 is connected to the pumpdevice 100, the user is provided with the opportunity to readily monitorinfusion pump operation by simply viewing the display 222 of thecontroller device 200. Such monitoring capabilities may provide comfortto a user who may have urgent questions about the current operation ofthe pump device 100 (e.g., the user may be unable to receive immediateanswers if wearing an infusion pump device having no user interfaceattached thereto). Moreover, the TIL information can be displayedcontemporaneously with the detected blood glucose value, so the user isprovided with the opportunity to make informed decisions regarding thecurrent and future status of his or her blood glucose level.

Also, in these embodiments, there may be no need for the user to carryand operate a separate module to monitor the operation of the infusionpump device 100, thereby simplifying the monitoring process and reducingthe number of devices that must be carried by the user. If a need arisesin which the user desires to monitor the operation of the pump device100 or to adjust settings of the pump system 10 (e.g., to request abolus amount of medicine), the user can readily operate the userinterface 220 of the controller device 200 without the requirement oflocating and operating a separate monitoring module.

In other embodiments, the user interface 200 is not limited to thedisplay and buttons depicted in FIGS. 1-2. For example, in someembodiments, the user interface 220 may include only one button or mayinclude a greater numbers of buttons, such as two buttons three buttons,four buttons, five buttons, or more. In another example, the userinterface 220 of the controller device 200 may include a touch screen sothat a user may select buttons defined by the active area of the touchscreen display. Alternatively, the user interface 220 may comprise audioinputs or outputs so that a user can monitor the operation of the pumpdevice 100.

Referring to FIGS. 3-4, the infusion pump system 10 may be configured tobe portable and can be wearable and concealable. For example, a user canconveniently wear the infusion pump assembly 60 on the user's skin(e.g., skin adhesive) underneath the user's clothing or carry the pumpassembly 60 in the user's pocket (or other portable location) whilereceiving the medicine dispensed from the pump device 100. The pumpdevice 100 may be arranged in a compact manner so that the pump device100 has a reduced length. For example, in the circumstances in which themedicine cartridge 120 has a length of about 7 cm or less, about 6 cm toabout 7 cm, and about 6.4 cm in one embodiment, the overall length ofthe pump housing structure 110 (which contains medicine cartridge andthe drive system) can be about 10 cm or less, about 7 cm to about 9 cm,and about 8.3 cm in one embodiment. In such circumstances, thecontroller device 200 can be figured to mate with the pump housing 110so that, when removably attached to one another, the components define aportable infusion pump system that stores a relatively large quantity ofmedicine compared to the overall size of the unit. For example, in thisembodiment, the infusion pump assembly 60 (including the removablecontroller device 200 attached to the pump device 100 having the cap130) may have an overall length of about 11 cm or less, about 7 cm toabout 10 cm, and about 9.6 cm in one embodiment; an overall height ofabout 6 cm or less, about 2 cm to about 5 cm, and about 4.3 cm in oneembodiment; and an overall thickness of about 20 mm or less, about 8 mmto about 20 mm, and about 18.3 mm in one embodiment.

The pump system 10 is shown in FIGS. 3-4 is compact so that the user canwear the portable infusion pump system 10 (e.g., in the user's pocket,connected to a belt clip, adhered to the user's skin, or the like)without the need for carrying and operating a separate module. In suchembodiments, the cap device 130 of the pump device 100 may be configuredto mate with the infusion set 70. In general, the infusion set 70 istubing system that connects the infusion pump system 10 to the tissue orvasculature of the user (e.g., to deliver medicine into the user'ssubcutaneous tissue or vasculature). The infusion set 70 may include theflexible tube 72 that extends from the pump device 100 to thesubcutaneous cannula 76 retained by a skin adhesive patch 78 thatsecures the subcutaneous cannula 76 to the infusion site. The skinadhesive patch 78 can retain the infusion cannula 76 in fluidcommunication with the tissue or vasculature of the patient so that themedicine dispensed through the tube 72 passes through the cannula 76 andinto the user's body. The cap device 130 may provide fluid communicationbetween the output end 122 (FIG. 2) of the medicine cartridge 120 andthe tube 72 of the infusion set 70. For example, the tube 72 may bedirectly connected to the output port 139 (FIG. 2) of the cap device130. In another example, the infusion set 70 may include a connector(e.g., a Luer connector or the like) attached to the tube 72, and theconnector can then mate with the cap device 130 to provide the fluidcommunication to the tube 72. In these examples, the user can carry theportable infusion pump assembly 60 (e.g., in the user's pocket,connected to a belt clip, adhered to the user's skin, or the like) whilethe tube 72 extends to the location in which the skin is penetrated forinfusion. If the user desires to monitor the operation of the pumpdevice 100 or to adjust the settings of the infusion pump system 10, theuser can readily access the user interface 220 of the controller device200 without the need for carrying and operating a separate module.

Referring to FIG. 3, in some embodiments, the infusion pump assembly 60is pocket-sized so that the pump device 100 and controller device 200can be worn in the user's pocket 6 or in another portion of the user'sclothing. For example, the pump device 100 and the controller device 200can be attached together and form the assembly 60 that comfortably fitsinto a user's pocket 6. The user can carry the portable infusion pumpassembly 60 and use the tube 72 of the infusion set 70 to direct thedispensed medicine to the desired infusion site. In some circumstances,the user may desire to wear the pump assembly 60 in a more discretemanner. Accordingly, the user may pass the tube 72 from the pocket 6,under the user's clothing, and to the infusion site where the adhesivepatch 78 is positioned. As such, the pump system 10 can be used todeliver medicine to the tissues or vasculature of the user in aportable, concealable, and discrete manner. Furthermore, the monitoringdevice 50 can be worn on the user's skin while the pump assembly 60 iscarried by the user (e.g., in a pocket). As such, the monitoring device50 can communicate information indicative of the user's blood glucoselevel to the pump assembly 60 while the pump assembly 60 is used todeliver medicine through the infusion set 70. In this embodiment, themonitoring device 50 may be arranged on the user's skin at a locationthat is spaced apart from the infusion set 70.

Referring to FIG. 4, in other embodiments, the infusion pump assembly 60may be configured to adhere to the user's skin 7 directly at thelocation in which the skin is penetrated for medicine infusion. Forexample, a rear surface of the pump device 100 may include a skinadhesive patch so that the pump device 100 is physically adhered to theskin of the user at a particular location. In these embodiments, the capdevice 130 may have a configuration in which medicine passes directlyfrom the cap device 130 into an infusion cannula 76 that is penetratedinto the user's skin. In one example, the fluid output port 139 throughthe cap device 130 can include a curve or a 90° corner so that themedicine flow path extends longitudinally out of the medicine cartridgeand thereafter laterally toward the patient's skin 7. Again, if the userdesires to monitor the operation of the pump device 100 or to adjust thesettings of the infusion pump system 10, the user can readily access theuser interface 220 of the controller device 200 without the need forcarrying and operating a second, separate device. For example, the usermay look toward the pump device 100 to view the user interface 220 ofthe controller device 200 that is removably attached thereto. In anotherexample, the user can temporarily detach the controller device 200(while the pump device 100 remains adhered to the skin 7) so as to viewand interact with the user interface 220. Furthermore, the monitoringdevice 50 can be worn on the user's skin while the pump assembly 60 isworn on the user's skin in a different location from that where themonitoring device is worn. As such, the monitoring device 50 cancommunicate information indicative of the user's blood glucose level tothe pump assembly 60 while the pump assembly 60 is used to delivermedicine through the infusion set 70. In this embodiment, the monitoringdevice 50 may be arranged on the user's skin at a location that isspaced apart from the infusion set 70.

In the embodiments depicted in FIGS. 3-4, the monitoring device 50adheres to the user's skin 7 at the location in which the skin ispenetrated by the sensor shaft 56 (to detect blood glucose levels). Thesensor shaft 56 (refer to FIG. 1) penetrates the skin surface for thepurpose of exposing the tip portion of the sensor shaft 56 to the tissueor the vasculature of the user. The sensor shaft 56 can detectinformation indicative of the user's blood glucose level and transferthis information to a circuit that is connected to the communicationsdevice 54 located within the monitoring device 50. The communicationdevice 54 can be in wireless communication with the communication device247 (described in connection with FIG. 9) included in the controllerdevice 200 of the pump assembly 60.

Referring now to FIGS. 5-8, in some embodiments, the infusion pumpassembly 60 can be operated such that the pump device 100 is adisposable, non-reusable component while the controller device 200 is areusable component. In these circumstances, the pump device 100 may beconfigured as a “one-time-use” device that is discarded after themedicine cartridge is emptied, expired, or otherwise exhausted. Thus, insome embodiments, the pump device 100 may be designed to have anexpected operational life of about 1 day to about 30 days, about 1 dayto about 20 days, about 1 to about 14 days, or about 1 day to about 7days—depending on the volume of medicine in the cartridge 120, thedispensation patterns that are selected for the individual user, andother factors. For example, in some embodiments, the medicine cartridge120 containing insulin may have an expected usage life about 7 daysafter the cartridge is removed from a refrigerated state and the septum121 (FIG. 2) is punctured. In some circumstances, the dispensationpattern selected by the user can cause the insulin to be emptied fromthe medicine cartridge 120 before the 7-day period. If the insulin isnot emptied from the medicine cartridge 120 after the 7-day period, theremaining insulin may become expired sometime thereafter. In eithercase, the pump device 100 and the medicine cartridge 120 therein can bediscarded after exhaustion of the medicine cartridge 120 (e.g., afterbeing emptied, expired, or otherwise not available for use).

The controller device 200, however, may be reused with subsequent newpump devices 100′ and new medicine cartridges 120′. As such, the controlcircuitry, the user interface components, and other components that mayhave relatively higher manufacturing costs can be reused over a longerperiod of time. For example, in some embodiments, the controller device200 may be designed to have an expected operational life of about 1 yearto about 7 years, about 2 years to about 6 years, or about 3 years toabout 5 years—depending on a number of factors including the usageconditions for the individual user. Accordingly, the user is permittedto reuse the controller device 200 (which may include complex orvaluable electronics) while disposing of the relatively low-cost pumpdevice 100 after each use. Such a pump system 10 can provide enhanceduser safety as a new pump device 100′ (and drive system therein) isemployed with each new fluid cartridge 120.

Referring to FIGS. 5-6, the pump device 100 can be readily removed fromthe controller device 200 when the medicine cartridge 120 is exhausted.As previously described, the medicine cartridge 120 is arranged in thecavity 116 (FIG. 2) of the pump housing 110 where it is retained by thecap device 130. In some embodiments, a portion of the pump housing 110can comprise a transparent or translucent material so that at least aportion of the medicine cartridge 120 is viewable therethrough. Forexample, the user may want to visually inspect the medicine cartridgewhen the plunger 125 is approaching the output end 122 of the medicinecartridge, thereby providing a visual indication that the medicinecartridge may be emptied in the near future. In this embodiment, thebarrel 111 of the pump housing 110 comprises a generally transparentpolymer material so that the user can view the medicine cartridge 120 todetermine if the plunger 125 is nearing the end of its travel length.

As shown in FIG. 5, the pump device 100 has been used to a point atwhich the medicine cartridge 120 is exhausted. The plunger 125 has beenadvanced, toward the left in FIG. 5, over a period of time so that allor most of the medicine has been dispensed from the cartridge 120. Insome embodiments, the controller device 200 may provide a visual oraudible alert when this occurs so as to remind the user that a newmedicine cartridge is needed. In addition or in the alternative, theuser may visually inspect the medicine cartridge 120 through the barrel111 of the pump housing 110 to determine if the medicine cartridge 120is almost empty. When the user determines that a new medicine cartridge120 should be employed, the pump device 100 can be readily separatedfrom the controller device 200 by actuating a release member 215. Inthis embodiment, the release member 215 is a latch on the controllerdevice 200 that is biased toward a locking position to engage the pumpdevice 100. The latch may be arranged to engage one or more features ona lateral side of the pump housing 110. As such, the user may actuatethe release member 215 by moving the release member 215 in a lateraldirection 216 (FIG. 5) away from the pump device 100 (e.g., by applyinga force with the user's finger).

As shown in FIG. 6, when the release member 215 is actuated and moved toa position away from the pump device 100, a segmented guide rail 114 a-bis free to slide longitudinally in a guide channel 214 a-b withoutinterference from the release member 215. Accordingly, the user can movethe pump device 100 in a longitudinal direction 217 away from thecontroller device 200. For example, the segmented guide rail 114 a-b mayslide along the guide channel 214 a-b, the extension 113 (FIG. 2) may bewithdrawn from the mating depression 213 (FIG. 6), and the electricalconnector 118 can be separated from the mating connector 218. In thesecircumstances, the pump device 100 is physically and electricallydisconnected from the controller device 200 while the pump deviceretains the exhausted medicine cartridge 120. It should be understoodthat, in other embodiments, other features or connector devices can beused to facilitate the side-by-side mounting arrangement. These otherfeatures or connector devices may include, for example, magneticattachment devices, mating tongues and grooves, or the like.

In some embodiments, the gasket 140 compressed between the pump device100 and the controller device 200 may comprise a resilient material. Insuch circumstances, the gasket 140 can provide a spring-action thaturges the pump device 100 to shift a small amount away from thecontroller device 200 when the release member 215 is moved to theunlocked position (e.g., moved in the lateral direction 216 in theembodiment shown in FIG. 5). Accordingly, in some embodiments, the pumpdevice 100 can automatically and sharply move a small distance (e.g.,about 0.5 mm to about 5 mm) away from the controller device 200 when therelease member 215 is moved to the unlocked position. Such an automaticseparation provides a convenient start for the user to detach the pumpdevice 100 away from the controller device 200. Furthermore, thisautomatic separation caused by the spring-action of the gasket 140 canprovide a swift disconnect between the electrical connectors 118 and 218when the pump device 100 is being replaced.

Referring to FIGS. 7-8, the same controller device 200 can be reusedwith a new pump device 100′ having a new medicine cartridge 120′retained therein, and the previously used pump device 100 can bediscarded with the exhausted medicine cartridge 120. The new pump device100′ (FIG. 7) can have a similar appearance, form factor, and operationas the previously used pump device 100 (FIGS. 5-6), and thus the newpump device 100′ can be readily attached to the controller device 200for controlled dispensation of medicine from the new medicine cartridge120′. In some embodiments, the user may prepare the new pump device 100′for use with the controller device 200. For example, the user may insertthe new medicine cartridge 120′ in the cavity 116 of the new pump device100′ and then join the cap device 130 to the pump housing to retain thenew medicine cartridge 120′ therein (refer, for example, to FIG. 2).Although the tubing 72 of the infusion set 70 is not shown in FIG. 7, itshould be understood that the tubing 72 may be attached to the capdevice 130 prior to the cap device 130 being joined with the housing110. For example, a new infusion set 70 can be connected to the capdevice 130 so that the tubing 72 can be primed (e.g., a selectedfunction of the pump device 100 controlled by the controller device 200)before attaching the infusion set patch to the user's skin. As shown inFIG. 7, the new medicine cartridge 120′ may be filled with medicine suchthat the plunger 125 is not viewable through the barrel 111. In someembodiments, the user can removably attach the pump device 100 to thecontroller device 200 by moving the pump device 100 in a longitudinaldirection 219 toward the controller device 200 such that the segmentedguide rail 114 a-b engages and slides within the guide channel 214 a-b.When the electrical connectors 118 and 218 mate with one another, therelease member 215 can engage the segmented guide rails 114 a-b toretain the pump device 100 with the controller device 200.

As shown in FIG. 8, the previously used pump device 100 that wasseparated from the controller device (as described in connection withFIGS. 5-6) may be discarded after a single use. In these circumstances,the pump device 100 may be configured as a disposable “one-time-use”device that is discarded by the user after the medicine cartridge 120 isemptied, is expired, has ended its useful life, or is otherwiseexhausted. For example, the pump device 100 may be discarded into a bin30, which may include a trash bin or a bin specifically designated fordiscarded medical products. Thus, the user is permitted to dispose ofthe relatively low-cost pump device 100 after each use while reusing thecontroller device 200 (which may include complex or valuableelectronics) with subsequent new pumps 100′. Also, in somecircumstances, the infusion set 70 (not shown in FIG. 8, refer toFIG. 1) that was used with the pump device 100 may be removed from theuser and discarded into the bin 30 along with the pump device 100.Alternatively, the infusion set 70 can be disconnected from the previouspump device 100 and attached to the new pump device 100′. In thesecircumstances, the user may detach the infusion set cannula 76 and patch78 from the skin so as to “re-prime” the tubing with medicine from thenew pump device 100′ to remove air pockets from the tubing. Thereafter,the infusion set cannula 76 and patch 78 can be again secured to theuser's skin.

Referring now to FIG. 9, the controller device 200 (shown in an explodedview) houses a number of components that can be reused with a series ofsuccessive pump devices 100. In particular, the controller device 200includes control circuitry 240 arranged in the controller housing 210that is configured to communicate control signals to the drive system ofthe pump device 100. In this embodiment, the control circuitry 240includes a main processor board 242 that is in communication with apower supply board 244. The control circuitry 240 includes at least oneprocessor 243 that coordinates the electrical communication to and fromthe controller device 200 (e.g., communication between the controllerdevice 200 and the pump device 100). The processor 243 can be arrangedon the main processor board 242 along with a number of other electricalcomponents such as memory devices (e.g., memory chip 248). It should beunderstood that, although the main processor board 242 is depicted as aprinted circuit board, the main processor board can have other forms,including multiple boards, a flexible circuit substrate, and otherconfigurations that permit the processor 243 to operate. The controlcircuitry 240 can be programmable in that the user may provide one ormore instructions to adjust a number of settings for the operation ofthe infusion pump system 10. Such settings may be stored in the one ormore memory devices, such as the memory chip 248 on the processor board242. The control circuitry 240 may include other components, such assensors (e.g., occlusion sensors), that are electrically connected tothe main processor board 242. Furthermore, the control circuitry 240 mayinclude one or more dedicated memory devices that store executablesoftware instructions for the processor 243. The one or more memorydevices (e.g., the memory chip 248) can also store information relatedto a user's blood glucose level and total insulin load (described inmore detail in association with FIGS. 11-14) over a period of time.

As previously described, the controller device 200 can be electricallyconnected with the pump device 100 via mating connectors 118 and 218 sothat the control circuitry 240 can communicate control signals to thepump device 100 and receive feedback signals from components housed inthe pump device 100. In this embodiment, the electrical connector 118(FIG. 2) on the pump device 100 is a z-axis connector, and the connector218 (FIG. 6) on the controller device 200 is adapted to mate therewith.The electrical connector 218 on the controller device 200 is incommunication with the control circuitry 240. As such, the processor 243can operate according to software instructions stored in the memorydevice so as to send control signals to the pump device 100 via theconnector 218.

Still referring to FIG. 9, the user interface 220 of the controllerdevice 200 can include input components, output components, or both thatare electrically connected to the control circuitry 240. For example, inthis embodiment, the user interface 220 includes a display device 222having an active area that outputs information to a user and fourbuttons 224 a-d that receive input from the user. Here, the display 222may be used to communicate a number of status indicators, settings,and/or menu options for the infusion pump system 10. In someembodiments, the control circuitry 240 may receive the input commandsfrom the user's button selections and thereby cause the display device222 to output a number of status indicators (e.g., if the pump system 10is delivering insulin, if the user's blood glucose level is rising orfalling, and the like), menus, and/or program screens that showparticular settings and data (e.g., the user's blood glucose level, theuser's insulin load, the user's TIL % value, or the like). As previouslydescribed, the controller circuit 240 can be programmable in that theinput commands from the button selections can cause the controllercircuit 240 to change any one of a number of settings for the infusionpump system 100.

Some embodiments of the control circuitry 240 may include a cableconnector (e.g., a USB connection port, another data cable port, or adata cable connection via the electrical connection 218) that isaccessible on an external portion of the controller housing 210. Assuch, a cable may be connected to the control circuitry 240 to uploaddata or program settings to the controller circuit or to download datafrom the control circuitry 240. For example, historical data of bloodglucose level, blood glucose alarm limits (including notification alertlimits and safety alarm limits), medicine delivery (including basal andbolus deliveries), and/or TIL information can be downloaded from thecontrol circuitry 240 (via the cable connector) to a computer system ofa physician or a user for purposes of analysis and program adjustments.Optionally, the data cable may also provide recharging power.

Referring to FIGS. 9-10, the control circuitry 240 of the controllerdevice 200 may include a second power source 245 (FIG. 9) that canreceive electrical energy from a first power source 345 (FIG. 10) housedin the pump device 100. In this embodiment, the second power source 245is coupled to the power supply board 244 of the control circuitry 240.The hard-wired transmission of the electrical energy can occur throughthe previously described connectors 118 and 218. In such circumstances,the first power source 345 may include a high density battery that iscapable of providing a relatively large amount of electrical energy forits package size, while the second power source 245 may include a highcurrent-output battery that is capable discharging a brief current burstto power the drive system 300 of the pump device 100. Accordingly, thefirst battery 345 disposed in the pump device 100 can be used to deliverelectrical energy over time (e.g., “trickle charge”) to the secondbattery 245 when the controller device 200 is removably attached to thepump device 100. For example, the first battery 345 may comprise azinc-air cell battery. The zinc-air cell battery 345 may have a largevolumetric energy density compared to some other battery types. Also,the zinc-air cell battery may have a long storage life, especially inthose embodiments in which the battery is sealed (e.g., by a removableseal tab or the like) during storage and before activation.

The second battery 245 may include a high current-output device that ishoused inside the controller housing 210. The second battery 245 can becharged over a period of time by the first battery 345 and thenintermittently deliver bursts of high-current output to the drive system300 over a brief moment of time. For example, the second battery 245 maycomprise a lithium-polymer battery. The lithium-polymer battery 245disposed in the controller device 200 may have an initial current outputthat is greater than the zinc-air cell battery 345 disposed in the pumpdevice 100, but zinc-air cell battery 345 may have an energy densitythat is greater than the lithium-polymer battery 245. In addition, thelithium-polymer battery 245 is readily rechargeable, which permits thezinc-air battery 345 disposed in the pump device 100 to provideelectrical energy to the lithium-polymer battery 245 for purposes ofrecharging. In alternative embodiments, it should be understood that thesecond power source 245 may comprise a capacitor device capable of beingrecharged over time and intermittently discharging a current burst toactivate the drive system 105.

Accordingly, the infusion pump system 10 having two power sources 345and 245—one arranged in the pump device 100 and another arranged in thereusable controller device 200—permits a user to continually operate thecontroller device 200 without having to recharge a battery via an outletplug-in or other power cable. Because the controller device 200 can bereusable with a number of pump devices 100 (e.g., attach the new pumpdevice 100′ after the previous pump device 100 is expended anddisposed), the second power source 245 in the controller device can berecharged over a period of time each time a new pump device 100 isconnected thereto. Such a configuration can be advantageous in thoseembodiments in which the pump device 100 is configured to be adisposable, one-time-use device that attaches to a reusable controllerdevice 200. For example, in those embodiments, the “disposable” pumpdevices 100 recharge the second power source 245 in the “reusable”controller device 200, thereby reducing or possibly eliminating the needfor separate recharging of the controller device 200 via a power cordplugged into a wall outlet.

Referring now to FIG. 10, the pump device 100 in this embodimentincludes the drive system 300 that is controlled by the removablecontroller device 200 (see FIG. 2). Accordingly, the drive system 300can accurately and incrementally dispense fluid from the pump device 100in a controlled manner. The drive system 300 may include a flexiblepiston rod 370 that is incrementally advanced toward the medicinecartridge 120 so as to dispense the medicine from the pump device 100.At least a portion of the drive system 300 is mounted, in thisembodiment, to the pump housing 110. Some embodiments of the drivesystem 300 may include a battery powered actuator (e.g., reversiblemotor 320 or the like) that actuates a gear system 330 to reset aratchet mechanism (e.g., including a ratchet wheel and pawl), a springdevice (not shown) that provides the driving force to incrementallyadvance the ratchet mechanism, and a drive wheel 360 that is rotated bythe ratchet mechanism to advance the flexible piston rod 370 toward themedicine cartridge 120. Connected to piston rod 370 is a pusher disc 375for moving the plunger 125 of the medicine cartridge 120.

Some embodiments of the drive system 300 can include a pressure sensor380 disposed between the plunger engagement device 375 and the plunger125 for determining the pressure within the fluid path (e.g., inside themedicine cartridge 120, the infusion set 70, and the like). For example,the fluid pressure in the medicine cartridge 120 can act upon theplunger 125, which in turn can act upon the pressure sensor 380 arrangedon the dry side of the plunger 125. The pressure sensor 380 may comprisea pressure transducer that is electrically connected (via one or morewires) to a gateway circuit 318 so that the sensor signals can becommunicated to the controller device 200 (e.g., via the electricalconnectors 118 and 218). As such, data from the pressure sensor 380 canbe received by the controller device 200 for use with, for example, anocclusion detection module to determine if an occlusion exists in themedicine flow path. Alternatively, the controller device 200 may includean optical sensor system (not shown in FIGS. 9-10) to detect occlusionsin the fluid path. For example, a light emitter and light sensor mayeach be arranged on a sensor circuit in the controller device 200 (butaligned with the pump device 100) so that the light sensor can detectthe amount of light emitted by the light emitter and subsequentlyreflected from a component adjacent the fluid path. The reflected lightlevel detected may be used to determine the pressure within the fluidpath.

Referring now to FIG. 11 which illustrates how, in some embodiments, thecontroller device 200 of infusion pump system 10 can be used to predicta user's blood glucose level at a particular future point in time. Ingeneral, the flow diagram depicts a process 500 that can be executed bythe pump controller device 200 that collects the necessary data tocalculate a blood glucose prediction, performs calculations, determineswhether to provide an alarm based on the predicted blood glucose level,prompts the user for input as to whether to take corrective action(s),and performs the corrective action(s) in accordance with the user'sresponse. The sub-process of collecting the data and making thecalculations can be repeated on a periodic basis, such as every 1minute, every 2 minutes, every 5 minutes, or on any other appropriatetime frequency basis.

At operation 510, the pump controller device 200 receives a user's bloodglucose data at time t_(n). The data is stored in the computer-readablememory of the controller device 200. The blood glucose data can beprovided to the pump controller device 200 in a number of ways. Forexample, the infusion pump system 10 (refer, for example, to FIG. 1) caninclude a glucose monitoring device such as glucose monitoring device 50of FIG. 1. In such a system, the glucose monitoring device 50 can be incommunication with the pump assembly 60 via wireless communications or awired connection. In other embodiments of the pump system 10, teststrips (e.g., blood test strips) containing a sample of the user's bloodcan be inserted into a strip reader portion of the pump assembly 60 thatcan test for the blood glucose level of the user's blood. Alternatively,the test strips (e.g., glucose test strips) containing a sample of theuser's blood can be inserted into a separate glucose meter device (notshown), which can then analyze the characteristics of the user's bloodand communicate the information (via a wired or wireless connection) tothe pump assembly 60. In still other embodiments, characteristics of theuser's blood glucose information can be entered directly into the pumpsystem 10 via a user interface on the controller device 200. Using suchexample techniques, the controller device 200 can receive the user'sblood glucose reading at point in time t_(n).

At operation 520, the pump controller device 200 can calculate theuser's blood glucose trend information at t_(n). For example, theglucose trend information can be determined using a curve-fit model thatlooks for blood glucose fluctuation patterns or trends can be applied tostored recent set of blood glucose measurements stored in the memory ofthe controller device 200 to thereby provide a rough indication of auser's blood glucose level at a time in the near future. Alternatively,the glucose trend information can be calculated in the monitoring deviceand then communicated to the controller device 200 for storage and usein this method. As described in more detail below, by using the bloodglucose trend information and along with other factors (such as theuser's TIL or IOB and, optionally, the food-on-board estimate), theaccuracy of blood glucose predictions can be significantly improved andprovide additional benefits to the user.

The blood glucose trend can be calculated, for example, based on apredictive statistical model applied to past blood glucose data points.In one such example, blood glucose data equations can be curve-fit andextrapolated using linear regression techniques to estimate the bloodglucose trajectory. In another example, the straight-line slope of therecent blood glucose data points can be determined and the slope of thefitted-line can be extrapolated to provide a prediction.

At operation 530, the user's insulin load (e.g., an estimated amount ofinsulin already delivered to the user's body, such as the TIL or IOB) attime t_(n) can be calculated. In the depicted embodiment, the process500 employs the IOB estimate for the user's insulin load. IOB accountsfor bolus insulin dosages (but not basal dosages) that have beendelivered but have not yet acted in the user's body. In general, theuser may select one or more bolus deliveries, for example, to offset theblood glucose effects caused by the intake of food (e.g., a “meal bolus”of insulin) or to correct for an undesirably high blood glucose level(e.g., a “correction bolus” of insulin). The bolus dosages can bedispensed in user-selected amounts based on calculations made by thecontroller device 200. For example, the controller device 200 can beinformed of a high glucose level (e.g., by user input, data receivedfrom the glucose monitoring device 50, or the like) and can make asuggestion to the user to administer a bolus of insulin to correct forthe high blood glucose reading (e.g., a “correction bolus”). In anotherexample, the user can request that the controller device 200 calculateand suggest a bolus dosage based, at least in part, on a proposed mealthat the user plans to consume (e.g., a “meal bolus”). As described inmore detail below in connection with operation 550, some implementationsof the process 500 may rely upon an IOB value that accounts for allbolus dosages (e.g., including both meal boluses and correction bolus)that have been delivered but have not yet acted in the user's body. Inother implementations, the process 500 may rely upon an IOB value thataccounts for only correction bolus dosages (e.g., exclude meal bolusdosages) that have been delivered but have not yet acted in the user'sbody (especially in circumstances where the user's FOB component is alsoexcluded from the calculation).

The insulin dispensed into the user's system may act over a period oftime to control the user's blood glucose level. As such, the user's bodymay include some amount of insulin that has not yet acted. The user'sfuture blood glucose level is likely to decline as the insulin loadtakes effect over time. Because the IOB has a potential for causing afuture drop in blood glucose, the process 500 can more accurately andmore rapidly predict a low blood glucose event.

The IOB can be determined in a manner that accounts for the substantialdelay between the time that insulin is delivered to the tissue of thesubcutaneous region and the time that this insulin reaches the bloodsupply. For example, the delay between a subcutaneous delivery of abolus dosage of insulin and the peak plasma insulin level achieved fromthis bolus can be one hour or more. Additionally, the bolus dosage maynot enter the blood stream all at once. As such, the effect of the boluscan peak at about one to two hours and then decay in a predictablemanner over as much as eight hours or more (described in more detail inconnection with FIG. 12). Due to the time decay effects of insulinactivity, the user could be susceptible to request a subsequent bolusdosage while some insulin from a previously delivered bolus dosage hasnot yet acted upon the user (a scenario sometimes referred to as “bolusstacking”). To reduce the likelihood of undesirable bolus stacking, andto improve the accuracy of a prediction of the user's future bloodglucose level, the IOB information can be determined by the controllerdevice 200 and subsequently used as a factor in a calculation of theuser's predicted blood glucose level at a future time.

In some embodiments, the controller device 200 can determine the IOB attime t_(n) based on bolus dosages that have been delivered to thepatient in the recent past. In some embodiments, for each bolus dosagedispensed within a predetermined period of time before t_(n) (e.g., 6hours, 7 hours, 7.5 hours, 8 hours, 10 hours, or the like), thecontroller device 200 can estimate the amount of bolus insulin that hasnot yet acted in the blood stream from time-decay models generated frompharmacodynamic data of the insulin. For example, a graph of anexemplary curve depicting the percent of insulin remaining versus timecan be seen in FIG. 12. In particular, FIG. 12 illustrates an example ofthe insulin action curve generated from pharmacodynamic data for theinsulin stored in the cartridge 120. Thus, in this embodiment, the IOBcalculation represents the sum of all recent bolus insulin dosageswherein each bolus insulin dosage is discounted by the active insulinfunction (which may be modeled on pharmacodynamic data as shown, forexample, in FIG. 12). In this manner, for example, the IOB can becalculated at operation 530.

Optionally, the process 500 may include operation 540 in whichfood-on-board data at a period in time t_(n) is received or otherwisedetermined by the controller device 200. The rationale for including thefood-on-board information in a predictive blood glucose algorithm isthat it takes time for carbohydrates consumed by a person to bemetabolized such that their full effects on the person's blood glucoselevel are realized. Therefore, yet-to-be-metabolized carbohydrates mayhave a direct impact on future blood glucose levels, and incorporatingsuch information can improve the accuracy of the process 500 forpredicting future blood glucose levels.

The controller device 200 can determine the food-on-board data componentbased on, for example, the total carbohydrates previously entered intothe controller device 200 as being consumed by the user during apredetermined period of time before t_(n) (e.g., 6 hours, 7 hours, 7.5hours, 8 hours, 10 hours, or the like). The previous food component canbe determined, for example, by estimating the amount of carbohydratesthat have been consumed but not yet metabolized by the user's body so asto affect the blood glucose level. For each of the previous food itemsreported by the user, the controller device 200 can estimate thepreviously consumed food that has not yet been metabolized from atime-based model generated from a standard glycemic index.Alternatively, when the user enters information regarding food intake,the user can be prompted to identify the metabolization “speed” of thefood item based on the glycemic index for that food. In thesecircumstances, the user may be prompted to input the amount of food(e.g., grams of Carbohydrate or another representative value) and thenidentify the glycemic index (via a numerical scale or from a list of twoor more choices (e.g., “fast” metabolization and “slow” metabolization)to provide a more accurate time-based function for specific meals. Whenthis yet-to-be-metabolized carbohydrate value is estimated, it can betreated as a “negative” insulin component in the predictive bloodglucose calculation by multiplying the yet-to-be-metabolizedcarbohydrate value by a carbohydrate ratio (e.g., 1 unit of insulin per15 grams of carbohydrates). In some embodiments, the calculated valuefor the food-on-board component can be displayed separately to the user(e.g., to provide the user with information regarding the effects of thepreviously consumed carbohydrates).

At operation 550, a predicted value for the user's future blood glucoselevel can be calculated by the controller device 200. In general, thecalculation can incorporate the data components described above inregard to process 500, such as the recently measured blood glucose level(at t_(n)), the trend model calculated from the recent set of bloodglucose measurements over a recent period of time, the IOB (at t_(n)),and optionally the food-on-board at (t_(n)). In addition, an insulinsensitivity factor (Si) can be included in the calculation. The insulinsensitivity factor represents the effect on a particular user's bloodglucose level in response to receiving a unit of insulin.

In a first preferred embodiment, the predicted value for the user'sfuture blood glucose level (PBG) can be calculated according to thefollowing algorithm that is executed by the pump controller:

PBG=BG+R*T−IOB*Si+Si*FOB/C

where:

-   -   PBG is the predicted blood glucose level;    -   BG is the blood glucose level at t_(n),    -   R is the rate of change of the trend of past blood glucose data        points;    -   T is the time increment into the future that the calculated PBG        pertains to;    -   IOB is the bolus insulin-on-board (IOB) at t_(n) as described        above;    -   Si is the insulin sensitivity factor (amount of blood glucose        change per unit of insulin);    -   FOB is the food-on-board at t_(n) estimate; and    -   C is the estimated carbohydrate ratio of the FOB (amount of        carbohydrates per unit of insulin).

The following example is provided to illustrate the formula above. Thisexample assumes the following data inputs:

BG (the blood glucose level at t_(n))=120 mg/dL;

R (the rate of change of past BG data points)=−2 mg/dL/min;

T (the time increment into the future)=10 minutes;

IOB at t_(n)=3 units;

Si (the user's insulin sensitivity factor)=20 mg/dL/unit;

FOB (the food-on-board at t_(n))=40 g; and

C (the carbohydrate ratio of the FOB)=20 g/unit.

Incorporating the above values in the aforementioned algorithm forcalculating a predicted blood glucose level (PBG) provides a value of:

PBG=120 mg/dL+(−2 mg/dL/min)*10 min−3 units*20 mg/dL/unit+20mg/dL/unit*(40 g)/(20 g/unit)=80 mg/dL.

Hence, the algorithm above has predicted that the user's blood glucoselevel 10 minutes in the future from tn will be 80 mg/dL, in comparisonto the current level of 120 mg/dL (at t_(n)). In contrast, if the IOBand the FOB were not included in the calculation, the PBG would havebeen 100 mg/dL. This example illustrates that including IOB estimateand, optionally, the food-on-board estimate in the predictivecalculation of blood glucose can likely improve the accuracy of theprediction.

The value for T (the time increment into the future of the predictivecalculation) can be selected based on a balance of practical factorsincluding: the user's ability to respond in a timely manner, the timeneeded for countermeasures to take effect, and the user's desired levelof control. In this embodiment, the value for T is a predeterminedparameter set by the supplier of the pump controller device 200. Inalternative embodiments, the value for T can be an adjustable parameterthat is selected by the user's clinician or the user himself or herself.In some embodiments, the value for T can be selected from a range of5-60 minutes, selected from a range of 5-30 minutes, and (in thisembodiment), selected to be 10 minutes in the example above.

As previously described, the value for the parameter Si can be differentfor different users, and as such a particular user may use his or herindividualized value for the improved accuracy of the blood glucoseprediction. The Si for a particular user can be input to the user'scontroller device 200 via the user interface 220, for example, by theuser's clinician or the user himself or herself.

In a second preferred embodiment, the predicted value for the user'sfuture blood glucose level (PBG) can be calculated according to thefollowing algorithm that is executed by the pump controller:

PBG=BG+R*T−TIL*Si+Si*FOB/C,

where:

-   -   PBG is the predicted blood glucose level;    -   BG is the blood glucose level at t_(n);    -   R is the rate of change of the trend of past blood glucose data        points;    -   T is the time increment into the future that the calculated PBG        pertains to;    -   TIL is the Total Insulin Load at t_(n) as described above;    -   Si is the insulin sensitivity factor;    -   FOB is the food-on-board at t_(n) estimate; and    -   C is the estimated carbohydrate ratio of the FOB.        This formula is different from the first preferred embodiment in        that it employs the TIL estimate instead of the IOB estimate. In        other words, the not-yet-acted insulin that was delivered to the        user as any of bolus dosages and basal dosages is included in        this algorithm (not merely insulin from the bolus dosages). In        some embodiments, the calculation of TIL can be performed by the        controller device 200. For example, the co-owned U.S. patent        application Ser. No. 12/251,629 (published as U.S. Patent        Publication No. 2010/0094251), which is hereby incorporated by        reference in its entirety, discloses systems and processes for        calculation of TIL that are applicable to the present        embodiment.

In a third alternative embodiment, the predicted value for the user'sfuture blood glucose level (PBG) can be calculated according to thefollowing algorithm that is executed by the pump controller:

PBG=BG+R*T −IOB_(correction)*Si

where:

-   -   PBG is the predicted blood glucose level;    -   BG is the blood glucose level at t_(n);    -   R is the rate of change of the trend of past blood glucose data        points;    -   T is the time increment into the future that the calculated PBG        pertains to;    -   IOB_(correction) is the bolus insulin-on-board for correction        boluses only (excluding meal bolus dosages) at t_(n) as        described above; and    -   Si is the insulin sensitivity factor.        This third embodiment employs a simplified equation that        eliminates the need to calculate or store the FOB. In general,        the aforementioned algorithm can focus on the correction-related        bolus dosages, and because the food-related bolus dosages (e.g.,        meal boluses) are not employed in the estimation for the insulin        remaining in the user's body that has not yet acted, the FOB        component may also not be employed. Such an algorithm can be        used to provide a reasonable approximation for the user's        predicted blood glucose level without necessarily requiring an        analysis of the FOB component.

In a fourth alternative embodiment that is partially similar to thethird embodiment described immediately above, the TIL_(correction)estimate can be substituted for IOB_(correction) estimate to result inthe predicted value for the user's future blood glucose level (PBG)calculated according to the following algorithm that is executed by thepump controller:

PBG=BG+R*T−TIL_(correction)*Si,

where:

-   -   PBG is the predicted blood glucose level;    -   BG is the blood glucose level at t_(n);    -   R is the rate of change of the trend of past blood glucose data        points;    -   T is the time increment into the future that the calculated PBG        pertains to;    -   TIL_(correctron) is the Total Insulin Load at t_(n) as described        above, except that the basal dosages and correction boluses only        and included (while meal bolus dosages are excluded);    -   Si is the insulin sensitivity factor.        Here again, this fourth embodiment employs a simplified equation        that eliminates the need to calculate or store the FOB. Because        the food-related bolus dosages (e.g., meal boluses) are not        employed in the estimation for the TIL_(correction), the FOB        component need not be employed in this example. Such an        algorithm can be used to provide a reasonable approximation for        the user's predicted blood glucose level without necessarily        requiring an analysis of the FOB component.

In a fifth alternative embodiment, the predicted value for the user'sfuture blood glucose level (PBG) can be calculated according to thefollowing algorithm that is executed by the pump controller:

PBG=BG−IOB*Si+Si*FOB/C,

where:

-   -   PBG is the predicted blood glucose level;    -   BG is the blood glucose level at t_(n);    -   IOB is the bolus insulin-on-board (IOB) at t_(n) as described        above;    -   Si is the insulin sensitivity factor;    -   FOB is the food-on-board at t_(n) estimate; and    -   C is the estimated carbohydrate ratio of the FOB.        In this embodiment, the controller device employs a simplified        equation that eliminates the use of the blood glucose trend        data.

In a sixth alternative embodiment that is partially similar to the fifthembodiment described immediately above, the TIL estimate can besubstituted for IOB estimate to result in the predicted value for theuser's future blood glucose level (PBG) calculated according to thefollowing algorithm that is executed by the pump controller:

PBG=BG−TIL*Si+Si*FOB/C,

where:

-   -   PBG is the predicted blood glucose level;    -   BG is the blood glucose level at t_(n);    -   TIL is the Total Insulin Load at t_(n) as described above;    -   Si is the insulin sensitivity factor;    -   FOB is the food-on-board at t_(n) estimate; and    -   C is the estimated carbohydrate ratio of the FOB.        Here again, in this embodiment, the controller device employs a        simplified equation that eliminates the use of the blood glucose        trend data.

In a seventh alternative embodiment, the predicted value for the user'sfuture blood glucose level (PBG) can be calculated according to thefollowing algorithm that is executed by the pump controller:

PBG=BG−IOB_(correction)*Si,

where:

-   -   PBG is the predicted blood glucose level;    -   BG is the blood glucose level at t_(n);    -   IOB_(correction) is the bolus insulin-on-board for correction        boluses only (excluding meal bolus dosages) at t_(n) as        described above; and    -   Si is the insulin sensitivity factor.        This seventh embodiment employs a simplified equation that        eliminates the use of blood glucose trend data and FOB. As        previously described, because the food-related bolus dosages        (e.g., meal boluses) are not employed in the estimation for the        IOB_(correction), the FOB component need not be employed in this        example.

In an eighth alternative embodiment that is partially similar to theseventh embodiment described immediately above, the TIL_(correction)estimate can be substituted for IOB_(correction) estimate to result inthe predicted value for the user's future blood glucose level (PBG)calculated according to the following algorithm that is executed by thepump controller:

PBG=BG−TIL_(correction)*Si

where:

-   -   PBG is the predicted blood glucose level;    -   BG is the blood glucose level at t_(n);    -   TIL_(correctron) is the Total Insulin Load at t_(n) as described        above, except that the basal dosages and correction boluses only        and included (while meal bolus dosages are excluded);    -   Si is the insulin sensitivity factor.        Here again, in this embodiment, the controller device employs a        simplified equation that eliminates the use of the blood glucose        trend data and FOB.

Still referring to FIG. 11, at operation 560, the process 500 can make acomparison between the calculated predicted blood glucose (PBG) fromoperation 550 and a lower threshold level to determine whether the PBGis below the lower threshold level (e.g., is the user's blood glucoselevel predicted to reach below a safety limit or otherwise predeterminedlimit). The lower threshold level can be generally considered as analarm/alert level (as described further below). Although it varies on anindividualized basis, generally when a person's blood glucose levelfalls below, for example 70 mg/dL, he or she may exhibit some symptomssuch as shakiness, feeling hungry, headaches, dizziness, and weakness.Below approximately 50 mg/dL, people tend to lose mental functioningincluding loss of consciousness, and they may slip into a coma.Therefore, in this example, a lower threshold level of 70 mg/dL can beconsidered to be a reasonable lower threshold level setting. However,the lower threshold level can be adjustable in response, for example, toan individual user's physiology, preferences, and medical advice. So, inthis embodiment, operation 560 represents the comparison of thecalculated PBG to the user's lower threshold level (e.g., 70 mg/dL inthis example).

If operation 560 indicates that the PBG is below the lower thresholdlevel, the process 500 has predicted a potential problem and the process500 moves on to operation 562. At operation 562, the user is presentedwith an alarm/alert message that communicates to the user that a futurelow blood glucose event is predicted, and asks whether the user wouldlike to enter a low glucose recovery mode (see, e.g., the display 222 ofFIG. 1). That is, in this embodiment, if the user's calculated PBG levelis below the lower threshold level, the controller device 200 cancommunicate a predicted low blood glucose alarm/alert to the user (e.g.,an audible alarm or alert, display of text on the display 222 describingan alarm or alert, a vibratory alarm or alert, another communicativeoutput, or a combination thereof). Optionally, the controller device 200can also prompt the user to take action to correct the predicted lowblood glucose level.

In one example, the controller device 200 (via user interface 220) cansuggest that the user consume some food to increase their blood glucoselevel, and can prompt the user to accept, modify, or decline thesuggestion. The controller device 200 can also prompt the user to enterinformation about a meal that the user may have consumed, but forgot toenter into the user interface 220. In another example, the controllerdevice 200 can use a cellular phone network (via Bluetooth connectivitywith a nearby cell phone or via a cell phone communication equipmentinstalled in the controller device 200) to call an emergency contactnumber programmed in the controller device 200.

In addition to alerting the user to the predicted low blood glucoselevel at operation 562, the user can be prompted to accept or declinethe option of initiating a low blood glucose recovery mode. If the userdeclines to enter the low glucose recovery mode, the process 500 movesto operation 590 which depicts the passage of a defined time incrementas described above. For example, if the defined time increment is oneminute, the process 500 will be restarted at operation 510 at timet_(n+1) which would be one minute after time t_(n). If the execution ofthe process steps 510 through 560 again results in a PBG level below thethreshold level, the user could once again be presented with analarm/alert concerning the predicted low blood glucose level. In thatcase, the user would receive a second alarm approximately just oneminute after declining to enter into the low glucose recovery mode. Someusers may consider such frequent alarms to be a nuisance. Therefore,some embodiments may include a feature in which the controller device200 modifies the alarm timer in response to the user declining to enterthe low blood glucose recovery mode. This feature can therefore providea “snooze” option.

Thus, the user may be provided with the option to “snooze” the predictedlow blood glucose alarm by declining to enter the low blood glucoserecovery mode while, for example, he or she is taking actions to resolvethe alarm circumstances. The settings that control the duration of the“snooze” timer can be modified to reduce the occurrences of repeatednuisance alarms or to increase the occurrence of serious safety alarms.For example, in some embodiments the following formula for determiningthe recurrence frequency (or “snooze” period) of alarms/alerts can beused:

time to wait=alarm urgency/(threshold level−PBG)

where:

-   -   “time to wait” is the calculated period during which        alarms/alerts will be automatically suppressed by the controller        device 200 “snooze function”;    -   “alarm urgency” is a factor that can be selected that represents        how frequently the particular user should be or desires to be        reminded of the alarms/alerts;    -   “threshold level” is the alarm/alert level as described above in        regard particularly to operation 560; and    -   PBG is the calculated predicted blood glucose level as described        above.

The “time to wait” formula can be illustrated by the following examples:

time to wait=60/(70−50)=3 minutes

time to wait=150/(70−60)=15 minutes

As shown, a lower “alarm urgency” value, and lower PBG values willresult in more frequent alarm reminders of a predicted low blood glucoselevel. The “alarm urgency” value can be adjusted based on theappropriate frequency of alarms for the particular user. The PBG valueswill also cause more frequent alarm reminders when the PBG values arefurther below the threshold level. In other words, more serious the PBGevents, the more frequent the alarm reminders. In this way, the user isdiscouraged from ignoring a potentially serious pending low bloodglucose event.

In some embodiments, the “time to wait” determination can include“brackets” that establish upper and lower “snooze” time limits thatwon't be exceed even if the calculation would tend to do so. Forexample, in some embodiments, “brackets” establishing a minimum of 1minute and a maximum of 30 minute can be established. In that case, noalarm reminder suppression period would ever be less than 1 minute ormore than 30 minutes. Any other appropriate bracket limits can also beused.

If, when presented with the PBG alarm and the option to enter the lowglucose recovery mode (at operation 562), the user enters an affirmativeresponse, then the process 500 moves to operation 564 whereat thecontroller device 200 enters the low glucose recovery mode. Theoperations of the controller device 200 in the low glucose recovery modecan be configured to alter the predicted path of the user's bloodglucose level so that the low blood glucose event is avoided. In oneexample, the operations in the low glucose recovery mode are describedin more detail below in regard to FIG. 14. Optionally, the process 500can be implemented in a manner that requires the user to confirm theactual blood glucose level using a blood strip reader (as a verificationof the level detected by the continuous monitoring device 50) prior tomoving to operation 564 whereat the controller device 200 enters the lowglucose recovery mode. In such optional embodiments, the controllerdevice 200 may be permitted to enter the low glucose recovery mode ifthe glucose level detected by the blood strip reader is within apredefined range of the lower threshold level (e.g., if the bloodglucose level detected from the blood glucose reader is within 15% ofthe lower threshold level). In addition, the controller device 200 canprompt the user to confirm that the blood glucose level detected fromthe blood glucose reader should be used to calibrate the readings fromcontinuous monitoring device 50. Optionally, the process 500 can besimilarly implemented in a manner that requires the user to confirm theactual blood glucose level using a blood strip reader (as a verificationof the level detected by the continuous monitoring device 50) prior toexiting the low glucose recovery mode.

After the low glucose recovery mode has been initiated, the process 500can optionally continue to operation 590 (refer also to operation 732 inFIG. 14). At 590, the time period of subsequent PBG calculations isincremented. For example, as described earlier, the process 500 can besetup to repeat on a defined time increment, e.g., every 1 minute, 2minutes, 5 minutes, 10 minutes, 30 minutes or the like. Operation 590depicts the expiration of a defined time increment and the initiation ofa new point in time for use in a new series of operations beginning at510 using time t_(n)=t_(n+1). For example, if the defined time incrementis one minute, then one minute after the point in time t_(n) the process500 can start over again. Note that the PBG calculations, represented byoperations 510 through 560, continue to be performed on a periodic basiseven when the controller device 200 has entered into the low bloodglucose recovery mode. That way the controller device 200 can track therecovery of the PBG level.

Referring back to operation 560, if the calculated PBG is at or abovethe lower threshold level, the process 500 may optionally proceed to anoperation 570 to make a comparison between the calculated predictedblood glucose (PBG) from operation 550 and an upper threshold level todetermine whether the PBG is above the upper threshold level (e.g., isthe user's blood glucose level predicted to reach above a safety limitor otherwise predetermined limit?). The upper threshold level can begenerally considered as an alarm/alert level (as described furtherbelow). Although it varies on an individualized basis, generally when aperson's blood glucose level rises above a safe range, he or she mayexhibit some symptoms such as excessive urination or thirst andtiredness. In this example, upper threshold level of 200 mg/dL can beconsidered to be a reasonable upper threshold level setting. However,the lower threshold level can be adjustable in response, for example, toan individual user's physiology, preferences, and medical advice. So, inthis embodiment, operation 570 represents the comparison of thecalculated PBG to the user's lower threshold level (e.g., 70 mg/dL inthis example).

If the PBG is above the upper threshold level, the process 500 haspredicted a potential problem and the process 500 moves on to operation572. At operation 572, the user is presented with an alarm/alert messagethat communicates to the user that a future high blood glucose event ispredicted, and asks whether the user would like to enter a high glucoserecovery mode (see, e.g., the display 222 of FIG. 1). That is, in thisembodiment, if the user's calculated PBG level is above the upperthreshold level, the controller device 200 can communicate a predictedhigh blood glucose alarm/alert to the user (e.g., an audible alarm oralert, display of text on the display 222 describing an alarm or alert,a vibratory alarm or alert, another communicative output, or acombination thereof).

In addition to alerting the user to the predicted high blood glucoselevel, the user can be prompted (at operation 572) to accept or declinethe option of initiating a high blood glucose recovery mode. If the userdeclines to enter the low glucose recovery mode, the process 500 movesto operation 590 which depicts the passage of a defined time incrementas described above. As previously described, if the defined timeincrement is one minute, the process 500 will be restarted at operation510 at time t_(n)+1 which would be one minute after time t_(n). If theexecution of the process steps 510 through 560 again results in a PBGlevel below the lower threshold level or above the upper thresholdlevel, the user could once again be presented with an alarm/alertconcerning the predicted low or high blood glucose level. In that case,the user would receive a second alarm approximately just one minuteafter declining to enter into the low glucose recovery mode. Some usersmay consider such frequent alarms to be a nuisance. Therefore, aspreviously described, some embodiments may include a feature in whichthe controller device 200 modifies the alarm timer in response to theuser declining to enter the low blood glucose recovery mode. Thisfeature can therefore provide a “snooze” option.

If, when presented with the PBG alarm and the option to enter the highglucose recovery mode at operation 572, the user enters an affirmativeresponse, then the process 500 moves to operation 574 whereat thecontroller device 200 enters the high glucose recovery mode. In the highglucose recovery mode, the process can cause the controller device 200to prompt the user to take action to correct the predicted high bloodglucose level. In one example, the controller device 200 (via userinterface 220) can suggest that the user accept a bolus dosage ofinsulin or to temporarily increase the basal rate of insulin, and canprompt the user to accept, modify, or decline the suggestion. In anotherexample, the controller device 200 can use a cellular phone network (viaBluetooth connectivity with a nearby cell phone or via a cell phonecommunication equipment installed in the controller device 200) to callan emergency contact number programmed in the controller device 200.

Optionally, the process 500 can be implemented in a manner that requiresthe user to confirm the actual blood glucose level using a blood stripreader (as a verification of the level detected by the continuousmonitoring device 50) prior to moving to operation 574 whereat thecontroller device 200 enters the high glucose recovery mode. In suchoptional embodiments, the controller device 200 may be permitted toenter the high glucose recovery mode if the glucose level detected bythe blood strip reader is within a predefined range of the upperthreshold level (e.g., if the blood glucose level detected from theblood glucose reader is within 15% of the upper threshold level). Inaddition, the controller device 200 can prompt the user to confirm thatthe blood glucose level detected from the blood glucose reader should beused to calibrate the readings from continuous monitoring device 50.Optionally, the process 500 can be similarly implemented in a mannerthat requires the user to confirm the actual blood glucose level using ablood strip reader (as a verification of the level detected by thecontinuous monitoring device 50) prior to exiting the high glucoserecovery mode.

If the calculated PBG from operation 550 is at or above the lowerthreshold level (operation 560) and is also at or below the upperthreshold level (operation 570), no alarm/alert is required, and theprocess 500 can proceed to operation 580 in which the pump systemoperates in a normal mode. For example, in normal mode, the pump systemcan provide the previously programmed basal dosages and permit the userto receive bolus dosages at selected times (e.g., shortly before a mealor the like). When operating in normal mode as indicated by operation580, the process 500 continues to operation 590 so that the process 500can repeat itself at another point in time. In other words, if the PBGis at or above the lower threshold level (operation 560) and is also ator below the upper threshold level (operation 570), the process 500 canrepeat itself from the beginning after a particular time increment fromto has expired. The cycle of operations from 510 through 560 can therebybe continuously repeated on a periodic basis while the calculated PBG iswithin a selected range between the lower threshold level and the upperthreshold level. This can be done in the background with generally noneed for any user interaction while the pump system operates in theaforementioned normal mode.

The process 500 can be setup to repeat on a defined time increment,e.g., every 1 minute, 2 minutes, 5 minutes, 10 minutes, 30 minutes, orthe like. Operation 590 depicts the expiration of the defined timeincrement. For example, if the defined time increment is one minute,then one minute after tn the process can start over again (indicated inoperation 590 as time t_(n)=t_(n+1)).

Referring now to FIG. 12, in some embodiments, the controller device 200can calculate the IOB information (refer, for example, to operation 530in FIG. 11) using, at least in part, time-based models derived frompharmacodynamic data. As previously described, the IOB value of a usercan include a bolus insulin load amount which may be determined using atime-decay model generated from pharmacodynamic data associated with theinsulin stored in the cartridge 120. As shown by way of example in FIG.12, the controller device 200 can utilize a time-decay curve(represented by curve 450), which is generated from pharmacodynamicdata, to estimate the percentage of insulin remaining in a user's bodyafter a particular period of time. It should be understood that thecontroller device 200 can be configured to utilize any one of a numberof selectable time-decay curves (only one of which is depicted in FIG.12 as curve 450) for purposes of estimating the percentage of insulinremaining in a user's body after a particular period of time. Forexample, the various time-decay curves that could be selected duringprogramming of the controller device 200 for a particular user mayinclude: curves with greater or smaller durations, linear approximationsof the curve 450 shown in FIG. 12 or other similar curves, hybrid curveshaving a curve similar to curve 450 in a first region and then followedby a linear decay in a second region, or a customized linearapproximation where the user or another person qualified to program thecontroller device 200 selects the slope (e.g., the rate of decay), theoverall time of consumption, or the like.

Referring now to FIG. 13, a graph exemplifying a user's blood glucoselevels as a function of time 600 is shown. In general, the graphincludes past trend data of blood glucose readings 610, a blood glucosereading at current time t_(n) 620, and two example predicted bloodglucose trends 630 and 640. This example of a user's past, present, andpredicted blood glucose levels will be used to illustrate some of thebenefits of including IOB and FOB (optionally) in a predictive bloodglucose algorithm.

The past trend data of blood glucose readings 610 depicts the user ashaving a declining trend pattern of past blood glucose levels. A curvecan be fit to the data 610 in order to help predict what the user'sfuture blood glucose levels will be. For example, the past trend data610 may indicate that the user's blood glucose level is declining at anaverage rate of −2 mg/dL per minute (as in the example calculationabove). Knowing the past rate of decline, and combining it with acurrent blood glucose level can enable a prediction of future bloodglucose levels.

A current (at time t_(n)) blood glucose level 620, represents the user'scurrent blood glucose level. The graph depicts the current blood glucoselevel 620 as approximately continuing the trend of falling blood glucoselevels to an extent that is similar to the pattern of past trend data610. Therefore, one could expect that the trend of declining bloodglucose levels would continue to decline at approximately the same ratein the future beyond time t_(n). For example, if the user's bloodglucose levels depicted by past trend data 610 and current level 620 aredeclining at an average rate of −2 mg/dL per minute, one could expectthat in one minute after tn the user's blood glucose level will become 2mg/dL less than the current blood glucose level 620. Extending thisexample further, one could expect that in two minutes after tn theuser's blood glucose level will become 4 mg/dL less that the currentblood glucose level 620, and so on.

The first predictive trend line 630 depicts an expected trend of futureblood glucose levels based solely on the past trend data 610 and thecurrent blood glucose level 620 at time t_(n). As shown, the slope ofthe first predictive trend line 630 is similar to the slope of a linethat would represent the past trend data 610 and current level 620.Using the first predictive trend line 630 the user's future bloodglucose levels can be predicted and compared to a threshold level todetermine whether to initiate an alarm. For example, as described inreference to FIG. 11, if a future blood glucose level on the firstpredictive trend line 630 is below the lower threshold level, the usercan be presented with an alarm and prompt the user to indicate whetherthe user would like to enter a low glucose recovery mode.

As described above, in some embodiments, including an IOB component in ablood glucose prediction can improve the accuracy of future bloodglucose predictions. To illustrate that, a second predictive trend line640 is provided that represents an expected trend of future bloodglucose levels based on the past trend 610, the current level 620, andan estimate of the user's IOB at time t_(n). As described in referenceto FIG. 12, some types of insulin can take hours to fully take effect ina user's body. Therefore, a recently infused bolus of insulin can beexpected to have a future downward influence on the user's blood glucoselevels—and the influence may not be fully captured in the past trenddata 610. In such a case, the second predictive trend line 640 (whichaccounts for the influence of IOB) may provide a more accurateprediction of the user's future blood glucose levels than would thefirst predictive trend line 630 (which does not necessarily account forthe impact of IOB on the user's future blood glucose levels). When thesecond predictive trend line 640 is compared to a blood glucosethreshold level, it may provide a different result than when the firstpredictive trend line 630 is compared to the threshold level. Forexample, as shown in FIG. 13, the second predictive trend line 640 islower than the first predictive trend line 630. In some cases, thesecond predictive trend line 640 may be below the lower blood glucosethreshold level while the first predictive trend line 630 is not belowthe lower threshold level. In that example scenario, the pump controllerdevice 200 would provide a predicted low blood glucose alarm when thealgorithm includes the influence of IOB, but not when the algorithmexcludes the influence of IOB. Thus, a pump controller device 200 thatpredicts the user's future blood glucose level by accounting for theinfluence of IOB can increase the accuracy of the prediction, and thepump controller device 200 could, in some circumstances, provide analarm to the user that might not otherwise be provided if the controllerdevice 200 did not account for the influence of IOB on the predictedblood glucose value.

Referring now to FIG. 14, some embodiments of a process 700 foroperating an insulin infusion pump can be used by an infusion pumpsystem to initiate a “low glucose recovery mode” when a future low bloodglucose event has been predicted. In this embodiment, the process 700may begin at operation 710 which depicts the normal activity of theinfusion pump system 10. The normal activity can include delivering tothe user scheduled basal dosages of insulin (or other medication) alongwith user-selected bolus dosages. The basal rate can be selected tomaintain a user's blood glucose level in a target range during normalactivity when the user is not eating or otherwise consuming food items.The selected bolus deliveries may provide substantially larger amountsof insulin to limit the blood glucose level during certaincircumstances, such as the consumption of carbohydrates and other fooditems.

At operation 712, the pump controller device 200 can predict a lowglucose event that may occur in the near future. For example, thecalculate a predicted blood glucose level (as described in detail abovein in connection with FIG. 11) that is below a lower threshold level,thereby indicating that the user's blood glucose level is on a path tofall below the lower threshold level. In some embodiments, as describedabove, the trend of past blood glucose data and the user's most recentblood glucose level can be employed to calculate a predicted bloodglucose level. As described above, an IOB estimation or a TIL estimationcan be included in the calculation in order to enhance the accuracy ofthe blood glucose prediction. Optionally, a food-on-board (FOB)estimation can also be included in the calculation in order to possiblyenhance the accuracy of the predicted blood glucose value at a futurepoint in time. Operation 712 in FIG. 14 is depicted as having predicteda low blood glucose event. Therefore, the subsequent operations ofprocess 700 take place as a result of this low blood glucose predictionat operation 712.

Optionally, the process 700 can be implemented in a manner that requiresthe user to confirm the actual blood glucose level using a blood stripreader (as a verification of the level detected by the continuousmonitoring device 50) prior to moving to the subsequent operations inwhich the controller device 200 enters the low glucose recovery mode. Aspreviously described, in such optional embodiments, the controllerdevice 200 may be permitted to enter the low glucose recovery mode ifthe glucose level detected by the blood strip reader is within apredefined range of the lower threshold level (e.g., if the bloodglucose level detected from the blood glucose reader is within 15% ofthe lower threshold level).

When the infusion pump system predicts that a low glucose level willoccur in the near future, the pump controller can be configured toinitiate or suggest one or more countermeasures in response. A number ofcountermeasures are described herein in connection with process 700.

For example, the process 700 may optionally include operation 714, whichcauses the immediate cancelation any remaining bolus dosage that has notyet dispensed to the user. In general, the user may select one or morebolus deliveries, for example, to offset the blood glucose effectscaused by the intake of food. The bolus dosages can be dispensed overtime in user-selected amounts based on calculations made by thecontroller device 200 in response, for example, to an indication fromthe user of how many carbohydrates they plan to consume. In someembodiments, the entire bolus amount may not be infused within a shorttime frame (e.g., within minutes). Rather, infusion of the bolus amountmay be spread over a greater period of time (e.g., a period of an houror more in some circumstances). Operation 714 depicts a scenario where alow blood glucose event is predicted during a period of time over whicha bolus amount is being infused. In such a scenario, the controllerdevice 200 can cancel any remaining bolus amount—in order to preventcausing the user's blood glucose level, which is already predicted tofall too low, from being driven further lower still. IN someembodiments, the operation 714 may be performed automatically (withoutuser input) after infusion pump system predicts that a low glucose levelwill occur in the near future. Alternatively, this operation 714 may beperformed only after confirming that the user accepts thiscountermeasure (e.g., only after receiving user input) in response tothe infusion pump system predicting that a low glucose level will occurin the near future.

At operation 716, the controller device 200 can output an alarm inassociation with the predicted low blood glucose event. For example, theuser can be presented with an alarm/alert message that communicates tothe user that a future low blood glucose event is predicted, and thatasks whether the user would like to enter a low glucose recovery mode(see, e.g., the display 222 of FIG. 1). That is, the controller device200 can communicate a predicted low blood glucose alarm/alert to theuser (e.g., an audible alarm or alert, display of text on the display222 describing an alarm or alert, a vibratory alarm or alert, anothercommunicative output, or a combination thereof). Optionally, thecontroller device 200 can also prompt the user to take remedial actionto correct the predicted low blood glucose level. In one example, thecontroller device 200 (via user interface 220) can suggest that the userconsume some food to increase their blood glucose level, and can promptthe user to accept, modify, or decline the suggestion. The controllerdevice 200 can also prompt the user to enter information about a mealthat the user may have consumed, but forgot to enter into the userinterface 220. In another example, the controller device 200 can use acellular phone network (for example, via Bluetooth connectivity with anearby cell phone or via a cell phone communication equipment installedin the controller device 200) to call an emergency contact numberprogrammed in the controller device 200.

In addition to alerting the user to the predicted low blood glucoselevel at operation 716, the pump controller can prompt the user toaccept or decline the corrective action of initiating a low bloodglucose recovery mode, as indicated at operation 718. In somealternative embodiments, in addition to the “yes” and “no” input optionsfrom the user associated with operation 718, the user may also choose to“snooze” the alarm (as described in connection with FIG. 11 above) tothereby postpone their decision, and to be presented with the promptagain after a period of time.

If the pump controller receives user input indicating that the userdeclines to accept the corrective action of entering the low glucoserecovery mode, the process 700 moves to operation 720. At operation 720,if some amount of a bolus was not yet infused and canceled at operation714 the user is informed via the user interface 220 how much bolus wasmissed. In such a case, the user may choose to take actions to make upfor the canceled bolus amount. After presenting the missed bolusinformation to the user, the controller device 200 can return theinfusion pump system 10 back to the normal pump activity at operation710.

If the user accepts the corrective action of entering the low glucoserecovery mode, the process 700 advances to operation 722. At operation722, the basal rate of the pump device 100 is reduced. It is desirableto reduce the basal rate because the infusion of additional insulin willtend to slow the recovery rate of the user's low blood glucose level.But, in some circumstances, it can be more desirable to continue toprovide a low basal flow rate rather than to completely stop the flow.For example, completely stopping the basal flow may contribute to clogsin the infusion line, whereas the continuation of a minimal flow levelcan reduce the likelihood of such problems.

At operation 724, the controller device 200 can optionally provideperiodic reminders to the user via the user interface 220 that theinfusion pump system 10 is in the lower glucose recovery mode. Thereminders can include textual messages and/or icons displayed on theuser interface 220. Audible or vibratory indications can be provided insome embodiments too. The periodic reminders may, in some embodiments,also include the display of a textual prompt on the user interface 220to treat the low glucose level by consuming food. In some embodiments,the reminders can be provided periodically on a basis of about every5-20 minutes. The reminders can also include an indication of an updatedpredicted blood glucose level so that the user can be aware of theprogress of their recovery from their low, or predicted low, bloodglucose status.

At operation 726, the process 700 can optionally disable the bolusprogramming function of the infusion pump system 10. Disablement(lock-out) of the bolus programming function when the user is in the lowblood glucose recovery mode can be desirable because the infusion ofadditional insulin would likely be counter-productive to the user'sefforts to maintain a blood glucose level in a safe range. Therefore,such an optional safety feature can be provided in some embodiments toprevent bolus infusions while the pump system 10 is in the low bloodglucose recovery mode. For example, in response to a user's attempt toprogram a bolus delivery while the pump system 10 is in the low bloodglucose recovery mode, the user interface 220 may display a messagealong the lines of: “No bolus allowed—glucose recovery mode in effect.”

At operation 728, the pump controller can optionally provide the userwith an option to manually override and exit the low glucose recoverymode. For example, the user can, in some embodiments, be provided withan ability to manually exit the low glucose recovery mode by making aparticular menu selections using buttons 224 a-d.

If the user chooses to manually exit the low blood glucose recoverymode, the process 700 advances to operation 730. At operation 730, theinfusion pump system 10 has exited the low glucose recovery mode andfuture alarms for predicted low glucose events can be suspended for aperiod of time. In some embodiments, the period of time that the alarmsare suspended for can be determined in part based on the seriousness theuser's low, or predicted low, blood glucose condition.

After operation 730, the process 700 can advance to operation 710 fornormal pump activity. However, in some embodiments, controller device200 can be programed to delay the resumption of normal operations of thepump system 10 when the user has manually exited the low glucoserecovery mode. In some embodiments, the duration of the delay ofresuming normal pump activity can depend in part on the seriousness ofthe user's low, or predicted low, blood glucose condition.

If the user does not manually exit the low blood glucose recovery mode,the infusion pump system 10 can continue in the low blood glucoserecovery mode, and the process 700 can advance to operation 732. Atoperation 732 the controller device 200 can continue to make bloodglucose prediction calculations on a periodic basis. For example, insome embodiments, operation 732 can generally be performed in the mannerand on a periodic time basis that is the same as or substantiallysimilar to the process 500 described above in reference to FIG. 11. Thepredictive calculations can be based on the blood glucose trend data,current blood glucose level, the IOB estimate (or the TIL estimate), andoptionally the FOB estimate, as with process 500. The calculations canbe performed on a periodic basis, e.g., every 1 minute, 2 minutes, 5minutes, and so on, as described above.

At operation 734, the calculated blood glucose prediction can becompared to a threshold level to determine whether the infusion pumpsystem 10 should continue in the low blood glucose recovery mode orwhether the infusion pump system 10 should exit from the low bloodglucose recovery mode to return to the normal mode. For example, whenthe calculated predicted blood glucose level is below the thresholdlevel, the process 700 can remain in the low blood glucose recovery modeand can return to operation 732. In contrast, when the calculatedpredicted blood glucose level is above the threshold level, the process700 can automatically (without manual intervention from the user) exitthe low blood glucose recovery mode and can return to the normal pumpactivity mode at operation 710. In such circumstances, the userinterface may notify the user (e.g., via the display device) that thelow glucose recovery mode was successful and the pump system hasreturned to a normal operation mode. Optionally, the process 700 can beimplemented in a manner that requires the user to confirm the actualblood glucose level using a blood strip reader (as a verification of thelevel detected by the continuous monitoring device 50) prior to exitingthe low glucose recovery mode and return to the normal pump activitymode at operation 710.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

1. (canceled)
 2. A medical infusion pump system, comprising: a portablepump housing that receives insulin for dispensation to a user, the pumphousing at least partially containing a pump drive system to dispensethe insulin through a flow path to the user; a controller thatcommunicates with the pump drive system to dispense the insulin from theportable pump housing, the controller being adapted to deliver basalinsulin and to receive commands to bolus insulin; and a monitoringdevice that communicates glucose information to the controller, theglucose information being indicative of a blood glucose level of theuser, wherein the controller is configured to predict a future bloodglucose level of the user based at least in part upon a recent bloodglucose level, a trend of blood glucose levels over time, and an insulinload of the user, and wherein the controller is configured to output analarm and automatically cancel any bolus insulin deliveries in progressin response to the predicted future blood glucose level being less thana lower threshold value, wherein the system further informs the user ofhow much bolus was missed.
 3. The system of claim 2, wherein thecontroller calculates the predicted future blood glucose level of theuser based at least in part upon the recent blood glucose level, thetrend of blood glucose levels over time, and the insulin load of theuser, the insulin load of the user being an estimated value ofpreviously dispensed insulin that has not yet acted in the user.
 4. Thesystem of claim 3, wherein the insulin load is an insulin-on-boardestimate indicative of bolus insulin dosages that have been dispensedbut not yet acted in the user.
 5. The system of claim 3, wherein theinsulin load is total-insulin-load estimate indicative of both bolus andbasal insulin dosages that have been dispensed but not yet acted in theuser.
 6. The system of claim 2, wherein the controller calculates thepredicted future blood glucose level of the user based at least in partupon the recent blood glucose level, the trend of blood glucose levelsover time, the insulin load of the user, and a food-on-board value, thefood-on-board value being indicative of previous food intake by the userthat has not yet metabolized in the user.
 7. The system of claim 2,further comprising one or more computer-readable memory devices of thecontroller that store the glucose information received from themonitoring device and time values associated with the glucoseinformation.
 8. The system of claim 7, wherein the one or morecomputer-readable memory devices of the controller storecomputer-readable instructions for a blood glucose prediction processthat, when executed by a processor of the controller, cause thecontroller to: calculate the predicted future blood glucose level of theuser based at least in part upon the recent blood glucose level, thetrend of blood glucose levels over time, and the insulin load of theuser; output the alarm in response to the predicted future blood glucoselevel being less than the lower threshold value; and operate in a lowglucose recovery mode in response to user input that confirms anoperational change for the controller.
 9. The system of claim 2, furthercomprising a user interface coupled to the controller, the userinterface including (i) a display device that is configured to provide avisual indication of the alarm and (ii) a user input device that isconfigured to receive user input to activate the controller to operatein a low glucose recovery mode.
 10. The system of claim 9, wherein inresponse to the activation of the controller to operate in the lowglucose recovery mode, the controller communicates with the pump drivesystem to reduce, but not stop, a basal rate amount of insulin to bedispensed the from the portable pump housing.
 11. The system of claim 9,wherein, in response to the activation of the controller to operate inthe low glucose recovery mode, the controller is configured to exit fromthe low glucose recovery mode based on a subsequent determination thatthe predicted future blood glucose level is greater than or equal to thelower threshold value.
 12. The system of claim 2, wherein in response tothe controller calculating the predicted future blood glucose levelbeing less than the lower threshold value, the controller automaticallycancels any previously scheduled bolus amount of insulin to be dispensedthe from the portable pump housing.
 13. The system of claim 2, whereinthe controller comprises a controller housing that removably attaches tothe pump housing, the controller being electrically connected to thepump drive system when the controller housing is removably attached tothe pump housing, wherein the controller is a reusable device while atleast one of the pump housing and the pump drive system include astructure to prevent reuse of the pump housing and the pump drivesystem.
 14. The system of claim 2, wherein the portable pump housingdefines an opening that slidably receives a prefilled cartridge of theinsulin, further comprising a cap device configured to cover the openingand pierce the prefilled cartridge of insulin when the portable pumphousing receives the prefilled cartridge of insulin.
 15. The system ofclaim 2, wherein the monitoring device comprises a portable housingwearable on the user's skin, a sensor shaft that penetrates into theuser's skin, and a wireless communication device to transmit the glucoseinformation to a wireless communication device of the controller.
 16. Acontroller for an insulin infusion pump system, comprising: a processor;one or more computer-readable memory devices that store the glucoseinformation received from the monitoring device and time valuesassociated with the glucose information, wherein the one or morecomputer-readable memory devices store computer-readable instructionsfor a blood glucose prediction process that, when executed by theprocessor, cause the controller to: active basal insulin delivery;receive instructions to deliver bolus insulin; calculate a predictedfuture blood glucose level of the user based at least in part upon arecent blood glucose level of a user, a trend of blood glucose levelsover time, and an insulin load of the user; output an alarm in responseto the predicted future blood glucose level being less than a lowerthreshold value; operate in a low glucose recovery mode in response touser input that accepts activation of the low glucose recovery mode, thelow glucose recover mode stopping the delivery of basal and bolusinsulin in progress; and outputting information about an amount of abolus that was not delivered due to the triggering of the low glucoserecovery mode.
 17. The controller of claim 16, wherein the one or morecomputer-readable memory devices store computer-readable instructionsfor the blood glucose prediction process that, when executed by theprocessor, cause the controller to: in response to the activation of thecontroller to operate in the low glucose recovery mode, reduce but notstop a basal rate amount of insulin to be dispensed while operating inthe low glucose recovery mode.
 18. The controller of claim 16, whereinthe one or more computer-readable memory devices store computer-readableinstructions for the blood glucose prediction process that, whenexecuted by the processor, cause the controller to: in response to theactivation of the controller to operate in the low glucose recoverymode, automatically exit from the low glucose recovery mode based on asubsequent determination that the predicted future blood glucose levelis greater than or equal to the lower threshold value.
 19. The system ofclaim 16, wherein the one or more computer-readable memory devices storecomputer-readable instructions for the blood glucose prediction processthat, when executed by the processor, cause the controller to: inresponse to the predicted future blood glucose level being less than thelower threshold value, automatically cancel any previously scheduledbolus dosage of insulin.
 20. A method of operating an insulin infusionpump system, comprising: receiving, at a controller of an insulininfusion pump system, glucose information indicative of a glucose levelof a user; determining an insulin load value indicative of an estimatedvalue of previously dispensed insulin that has not yet acted in theuser; calculating, at the controller of the insulin infusion pumpsystem, a predicted future blood glucose level of the user based atleast in part upon a recent glucose level of the user, a trend of bloodglucose levels over time, and the insulin load of the user; and inresponse to the predicted future blood glucose level being less than alower threshold value, outputting an alarm from the insulin infusionpump system, stopping the delivery of basal and bolus insulin, andoutputting information about an amount of bolus insulin that was notdelivered.
 21. The method of claim 20, further comprising, in responseto the predicted future blood glucose level being less than the lowerthreshold value or greater than the higher threshold value, promptingthe user to confirm a change to an operational mode of the insulininfusion pump system.